Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 7:32 PM
Study NCT ID:
NCT00844532
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'C564658', 'term': 'Peripheral Arterial Occlusive Disease 1'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.rutledge@av.abbott.com', 'phone': '408-845-3820', 'title': 'David R Rutledge', 'organization': 'Abbott Vascular'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'description': 'Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.', 'eventGroups': [{'id': 'EG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.', 'otherNumAtRisk': 151, 'otherNumAffected': 88, 'seriousNumAtRisk': 151, 'seriousNumAffected': 91}], 'otherEvents': [{'term': 'Arrhythmias (other than bradycardia)', 'notes': 'Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Hypotension', 'notes': 'Cardiac/Hemodynamic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Edema (non pulmonary)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 85, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}], 'seriousEvents': [{'term': 'Bleeding', 'notes': 'Access Site Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pain at insertion site', 'notes': 'Access Site Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pseudoaneurysm', 'notes': 'Access Site Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Anemia', 'notes': 'Blood Dyscrasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Thrombocytopenia', 'notes': 'Blood Dyscrasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Arrhythmias (other than bradycardia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Surgery/Interventional Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Cardiac Arrest', 'notes': 'Cardiac/Hemodynamic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Hypertension', 'notes': 'Cardiac/Hemodynamic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Hypotension', 'notes': 'Cardiac/Hemodynamic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Syncope', 'notes': 'Cardiac/Hemodynamic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Gastrointestinal Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Gastro-intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Gastro-intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Facial Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Foot Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Inguinal Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Viral, bacterial and fungal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Wound complication or wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Genito-urinary', 'notes': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Headache', 'notes': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Musculoskeletal', 'notes': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Non Cardiac Chest Pain', 'notes': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Surgery/Interventional Procedure', 'notes': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Wound complication or wound infection', 'notes': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Myocardial Infarction - Non-Q- wave', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Myocardial Infarction - Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Non Stemi MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Confusion', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Mental Status Change', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Myalgia', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Hydrocephalus', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Anoxic Encephalopathy', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Anxiety', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Extremity Tremors', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Metabolic Encephalopathy', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Subarachnoid/Intracerebral Hemorrhage', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Seizure', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Surgery/Interventional Procedure', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Transient Ischemic Attack', 'notes': 'Neurologic other than stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Dissection', 'notes': 'Procedure-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Hypertension', 'notes': 'Procedure-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'notes': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Pleural Effusion', 'notes': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Drug Toxicity', 'notes': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Dyspnea', 'notes': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Shortness Of Breath', 'notes': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pneumonia', 'notes': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Respiratory Failure', 'notes': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: cerebrovascular accident', 'notes': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Right Cerebellar Infarct', 'notes': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Stroke: Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Carotid Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Other: Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 25, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 31, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Surgery/Interventional Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott Categories'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Adverse Event (MAE) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'comment': 'One-sided 95% confidence interval was computed for this endpoint, lower bound is not provided.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '10.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'devices', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '98.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'acute: from beginning of index procedure to end of index procedure.', 'description': 'On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).', 'unitOfMeasure': 'percentage of devices', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'devices', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'target lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '81.5', 'upperLimit': '91.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'acute: from beginning of index procedure to end of index procedure.', 'description': 'Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of \\< 30% by QA or as reported by the investigator, if QA is not available.', 'unitOfMeasure': 'percentage of target lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'target lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000', 'lowerLimit': '78.8', 'upperLimit': '90.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner', 'description': 'Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-procedure', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per target limb analysis.ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-procedure', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Walking Distance Score', 'categories': [{'measurements': [{'value': '14.0', 'spread': '19.9', 'groupId': 'OG000'}]}]}, {'title': 'Walking Speed Score', 'categories': [{'measurements': [{'value': '17.9', 'spread': '20.8', 'groupId': 'OG000'}]}]}, {'title': 'Stair Climbing Score', 'categories': [{'measurements': [{'value': '22.7', 'spread': '23.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Walking Distance Score (N=134)', 'categories': [{'measurements': [{'value': '53.8', 'spread': '37.6', 'groupId': 'OG000'}]}]}, {'title': 'Walking Speed Score (N=135)', 'categories': [{'measurements': [{'value': '51.8', 'spread': '33.5', 'groupId': 'OG000'}]}]}, {'title': 'Stair Climbing Score (N=127)', 'categories': [{'measurements': [{'value': '55.9', 'spread': '36.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Walking Distance Score (N=127)', 'categories': [{'measurements': [{'value': '55.7', 'spread': '39.6', 'groupId': 'OG000'}]}]}, {'title': 'Walking Speed Score (N=126)', 'categories': [{'measurements': [{'value': '50.6', 'spread': '33.9', 'groupId': 'OG000'}]}]}, {'title': 'Stair Climbing Score (N=119)', 'categories': [{'measurements': [{'value': '59.2', 'spread': '37.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Walking Distance Score (N=99)', 'categories': [{'measurements': [{'value': '58.2', 'spread': '37.1', 'groupId': 'OG000'}]}]}, {'title': 'Walking Speed Score (N=99)', 'categories': [{'measurements': [{'value': '50.6', 'spread': '32.4', 'groupId': 'OG000'}]}]}, {'title': 'Stair Climbing Score (N=95)', 'categories': [{'measurements': [{'value': '59.1', 'spread': '36.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.'}, {'type': 'SECONDARY', 'title': 'Walking Impairment Questionaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Walking Distance Score (N=94)', 'categories': [{'measurements': [{'value': '54.1', 'spread': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Walking Speed Score (N=94)', 'categories': [{'measurements': [{'value': '49.2', 'spread': '33.0', 'groupId': 'OG000'}]}]}, {'title': 'Stair Climbing Score (N=88)', 'categories': [{'measurements': [{'value': '58.9', 'spread': '37.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.'}, {'type': 'SECONDARY', 'title': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Procedure', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Improved by >/= 3 categories', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 2 categories', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 1 category', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between baseline and 1 month', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Improved by >/= 3 categories', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 2 categories', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 1 category', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between baseline and 9 months', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Improved by >/= 3 categories', 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 2 categories', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 1 category', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between baseline and 2 years', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': 'Improved by >/= 3 categories', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 2 categories', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}]}]}, {'title': 'Improved by 1 category', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between baseline and 3 years', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.', 'unitOfMeasure': 'Percentage of Limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '1 month', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month and 9 months', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesion', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesion', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '1 month', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month and 9 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).', 'unitOfMeasure': 'percentage of target lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '1 month', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month and 9 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '1 month', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month and 9 months', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).', 'unitOfMeasure': 'percentage of target vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'title': '1 month', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month and 9 months', 'description': 'Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).', 'unitOfMeasure': 'percentage of limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).', 'unitOfMeasure': 'percentage of limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).', 'unitOfMeasure': 'percentage of limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population. 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[{'value': '99.3', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month and 9 months', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.This analysis represents those subjects who were event free at this time point.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Embolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.This analysis represents those subjects who were event free at this time point.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Embolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.This analysis represents those subjects who were event free at this time point.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Freedom From Embolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.This analysis represents those subjects who were event free at this time point.'}, {'type': 'SECONDARY', 'title': 'Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}, {'units': 'Limbs', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.', 'unitOfMeasure': 'percentage of limbs', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Participants', 'populationDescription': 'ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '12.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 9 months', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '12.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '11.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '10.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 9 months', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '13.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life Measures: Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '12.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Trial population is comprised of male and female subjects with moderate to severe iliac artery atherosclerotic occlusive disease. Recruitment dates: March 23, 2009 through May 17, 2010'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '98', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2011-12-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-14', 'studyFirstSubmitDate': '2009-02-12', 'dispFirstSubmitQcDate': '2012-02-28', 'resultsFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2009-02-13', 'dispFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-07', 'studyFirstPostDateStruct': {'date': '2009-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Event (MAE) Rate', 'timeFrame': '9 months', 'description': 'Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).'}], 'secondaryOutcomes': [{'measure': 'Device Success', 'timeFrame': 'acute: from beginning of index procedure to end of index procedure.', 'description': 'On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).'}, {'measure': 'Technical Success', 'timeFrame': 'acute: from beginning of index procedure to end of index procedure.', 'description': 'Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of \\< 30% by QA or as reported by the investigator, if QA is not available.'}, {'measure': 'Procedure Success', 'timeFrame': 'Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner', 'description': 'Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.'}, {'measure': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': 'Pre-procedure', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.'}, {'measure': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': 'Post-procedure', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.'}, {'measure': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '1 month', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.'}, {'measure': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '9 months', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.'}, {'measure': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '2 years', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.'}, {'measure': 'Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '3 years', 'description': 'The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.'}, {'measure': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': 'Post-procedure', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.'}, {'measure': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '1 month', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.'}, {'measure': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '9 months', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.'}, {'measure': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '2 years', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.'}, {'measure': 'Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)', 'timeFrame': '3 years', 'description': 'The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.'}, {'measure': 'Walking Impairment Questionaire Scores', 'timeFrame': 'Pre-procedure', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).'}, {'measure': 'Walking Impairment Questionaire Scores', 'timeFrame': '1 month', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).'}, {'measure': 'Walking Impairment Questionaire Scores', 'timeFrame': '9 months', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).'}, {'measure': 'Walking Impairment Questionaire Scores', 'timeFrame': '2 years', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ)'}, {'measure': 'Walking Impairment Questionaire Scores', 'timeFrame': '3 years', 'description': 'Measured by the Walking Impairment Questionnaire (WIQ)'}, {'measure': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': 'Pre-Procedure', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable'}, {'measure': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': '1 month', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable'}, {'measure': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': '9 months', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable'}, {'measure': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': '2 years', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable'}, {'measure': 'Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': '3 years', 'description': 'The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.\n\nCategory and Clinical Description:\n\n0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable'}, {'measure': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': 'Between baseline and 1 month', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.'}, {'measure': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': 'Between baseline and 9 months', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.'}, {'measure': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': 'Between baseline and 2 years', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.'}, {'measure': 'Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)', 'timeFrame': 'Between baseline and 3 years', 'description': 'Change in Rutherford Becker Clinical Category:\n\nWorsening Rutherford Becker Clinical Category:\n\nDeterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.\n\nImproved Rutherford Becker Clinical Category:\n\nAn improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'timeFrame': '1 month and 9 months', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'timeFrame': '18 months', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'timeFrame': '2 years', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)', 'timeFrame': '3 years', 'description': 'Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'timeFrame': '1 month and 9 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'timeFrame': '18 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'timeFrame': '2 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)', 'timeFrame': '3 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \\<50% stenosis, while treating a non-target lesion in the target vessel).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'timeFrame': '1 month and 9 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'timeFrame': '18 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'timeFrame': '2 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)', 'timeFrame': '3 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'timeFrame': '1 month and 9 months', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'timeFrame': '18 months', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'timeFrame': '2 years', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)', 'timeFrame': '3 years', 'description': 'Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)', 'timeFrame': '1 month and 9 months', 'description': 'Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)', 'timeFrame': '18 months', 'description': 'Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)', 'timeFrame': '2 years', 'description': 'Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)', 'timeFrame': '3 years', 'description': 'Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).'}, {'measure': 'Primary Stent Patency', 'timeFrame': '1 month', 'description': 'Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.'}, {'measure': 'Primary Stent Patency', 'timeFrame': '9 months', 'description': 'Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.'}, {'measure': 'Primary Stent Patency', 'timeFrame': '2 years', 'description': 'Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.'}, {'measure': 'Primary Stent Patency', 'timeFrame': '3 years', 'description': 'Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.'}, {'measure': 'Restenosis', 'timeFrame': '9 months', 'description': 'Defined as ≥ 50% stenosis at follow-up.'}, {'measure': 'Restenosis', 'timeFrame': '2 years', 'description': 'Defined as ≥ 50% stenosis at follow-up.'}, {'measure': 'Restenosis', 'timeFrame': '3 years', 'description': 'Defined as ≥ 50% stenosis at follow-up.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Death (All Cause)', 'timeFrame': '1 month and 9 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Death (All Cause)', 'timeFrame': '18 months', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Death (All Cause)', 'timeFrame': '2 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Death (All Cause)', 'timeFrame': '3 years', 'description': 'Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)', 'timeFrame': '1 month and 9 months', 'description': 'The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)', 'timeFrame': '18 months', 'description': 'The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)', 'timeFrame': '2 years', 'description': 'The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)', 'timeFrame': '3 years', 'description': 'The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)', 'timeFrame': '1 month and 9 months', 'description': 'Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)', 'timeFrame': '18 months', 'description': 'Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)', 'timeFrame': '2 years', 'description': 'Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)', 'timeFrame': '3 years', 'description': 'Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Embolic Events', 'timeFrame': '1 month and 9 months', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Embolic Events', 'timeFrame': '18 months', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Embolic Events', 'timeFrame': '2 years', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery'}, {'measure': 'Kaplan-Meier Estimate of Freedom From Embolic Events', 'timeFrame': '3 years', 'description': 'Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery'}, {'measure': 'Stent Thrombosis', 'timeFrame': '1 month', 'description': 'Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.'}, {'measure': 'Changes in Quality of Life Measures: Physical Component Summary', 'timeFrame': 'Baseline and 1 month', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}, {'measure': 'Changes in Quality of Life Measures: Physical Component Summary', 'timeFrame': 'Baseline and 9 months', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}, {'measure': 'Changes in Quality of Life Measures: Physical Component Summary', 'timeFrame': 'Baseline and 2 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}, {'measure': 'Changes in Quality of Life Measures: Physical Component Summary', 'timeFrame': 'Baseline and 3 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}, {'measure': 'Changes in Quality of Life Measures: Mental Component Summary', 'timeFrame': 'Baseline and 1 month', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}, {'measure': 'Changes in Quality of Life Measures: Mental Component Summary', 'timeFrame': 'Baseline and 9 months', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}, {'measure': 'Changes in Quality of Life Measures: Mental Component Summary', 'timeFrame': 'Baseline and 2 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}, {'measure': 'Changes in Quality of Life Measures: Mental Component Summary', 'timeFrame': 'Baseline and 3 years', 'description': "This measure indicates the absolute change between two timepoints represented by the mean.\n\nSF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Peripheral artery disease', 'Peripheral vascular disease', 'PAD', 'Claudication', 'Peripheral Arterial Occlusive Disease', 'Stent', 'PAOD', 'PVD'], 'conditions': ['Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Clinical Inclusion Criteria:\n\n1. Subject must be at least 18 and \\< 90 years of age.\n2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.\n3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.\n4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).\n5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.\n\nAngiographic Inclusion Criteria\n\n1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).\n2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)\n3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis\n4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)\n5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm\n6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro)\n7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as \\< 50% stenosis.\n8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).\n9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite).\n\nClinical Exclusion Criteria\n\n1. Subject is unable to walk.\n2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.\n3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).\n4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.\n5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).\n6. Subject has elevated serum creatinine \\> 2.0 mg/dl.\n7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose \\> 400 mg/dl).\n8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.\n9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk.\n10. Subject has unstable angina defined as rest angina with ECG changes.\n11. Subject has a groin infection, or an acute systemic infection that is currently under treatment.\n12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.\n13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure.\n14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years).\n15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints.\n16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.\n17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.\n18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®).\n19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.\n20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.\n21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.\n22. Requirement of general anesthesia or spinal block for the procedure.\n23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.\n24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.\n25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.\n26. Target lesion is in an iliac artery that has been previously stented.\n\nAngiographic Exclusion Criteria\n\n1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.\n2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion\n3. Target lesion is within or adjacent to an aneurysm.\n4. Lesion is located within or beyond a vessel that contains a bypass graft.\n5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.\n6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm \\> 3cm.\n7. Lesion extends beyond the inguinal ligament.\n8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.\n9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.\n10. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as \\< 50% stenosis.\n11. Requirement for \\> 1 stent to treat full length of lesion.'}, 'identificationModule': {'nctId': 'NCT00844532', 'acronym': 'MOBILITY AP', 'briefTitle': 'Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Prospective, Non-randomized, 2 Arm (AP Arm & Omni-Link Elite [OE] Arm-separately Posted as: NCT01396525), Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery. CAUTION: The Omnilink Elite™ Peripheral Balloon-expandable Stent System is an Investigational Device. Limited by Federal (U.S.) Law to Investigational Use Only.', 'orgStudyIdInfo': {'id': '08-107 Absolute Pro Arm (AP)'}, 'secondaryIdInfos': [{'id': '08-107 OE', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'description': 'Arm includes both Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems', 'interventionNames': ['Device: Absolute Pro™ Peripheral Self-Expanding Stent System']}], 'interventions': [{'name': 'Absolute Pro™ Peripheral Self-Expanding Stent System', 'type': 'DEVICE', 'description': 'Absolute Pro™ Peripheral Self-Expanding Stent System: Devices include both Absolute Pro™ and Absolute Pro™ LL Peripheral Self-Expanding Stent Systems. It is indicated for the treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).', 'armGroupLabels': ['Absolute Pro™ Peripheral Self-Expanding Stent System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95054', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Abbott Vascular', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}], 'overallOfficials': [{'name': 'Tony S. Das, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Presbyterian Heart Institute, Dallas, TX'}, {'name': 'Manish Mehta, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany Medical Center, Albany, NY.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}