Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT01925794
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2013-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbarakat@celonova.com', 'phone': '(210) 489-4004', 'title': 'Mark Barakat, MD', 'organization': 'CeloNova BioSciences Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days', 'eventGroups': [{'id': 'EG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent System', 'otherNumAtRisk': 296, 'deathsNumAtRisk': 283, 'otherNumAffected': 0, 'seriousNumAtRisk': 296, 'deathsNumAffected': 34, 'seriousNumAffected': 87}], 'seriousEvents': [{'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Impaired Healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Necrotising Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nosocomial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oophoritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Salpingitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arterial Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arterial Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary Artery Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Post Pocedural Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Procedural Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vascular Access Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood Creatinine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac Enzymes Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Electrocardiogram Change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bile Duct Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung Adenocarcinoma Stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pleural Mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Parkinsonian Gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vascular Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Calculus Ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arterial Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intermittent Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '11.38', 'groupId': 'OG000', 'lowerLimit': '7.96', 'upperLimit': '15.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '270 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Death from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Death from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Death from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Death from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1800 days', 'description': 'Death from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Cardiac Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Cardiac Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Cardiac Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Cardiac Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '3.99', 'groupId': 'OG000', 'lowerLimit': '1.68', 'upperLimit': '6.29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1800 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Events (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '26.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1800 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI-ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'title': 'Q-wave MI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non Q-wave MI', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'MI-ARC Definition', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves (historical definition). ARC definition includes Troponin or CK-MB \\>3 x UNL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI-ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'title': 'Q-wave MI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non Q-wave MI', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'MI-ARC Definition', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI-ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'title': 'Q-wave MI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non Q-wave MI', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'MI-ARC Definition', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI-ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'title': 'Q-wave MI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Non Q-wave MI', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'MI-ARC Definition', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI-ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '6.62', 'upperLimit': '13.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1800 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death or MI (ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Composite Endpoint of Cardiac Death or MI (ARC definition)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death or MI (ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Composite Endpoint of Cardiac Death and MI (ARC definition)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death or MI (ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Composite Endpoint of Cardiac Death or MI (ARC definition)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Cardiac Death or MI (ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Composite Endpoint of Cardiac Death or MI (ARC definition)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TLR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TLR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TLR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TLR (Clinical and Angiographic Cohorts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TLR (Clinical Cohorts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TLR (Clinical and Angiographic Cohorts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8.20', 'upperLimit': '15.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1800 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TLR (Clinical Cohorts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '7.76', 'groupId': 'OG000', 'lowerLimit': '3.69', 'upperLimit': '11.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1800 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Clinically Driven TVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI) \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI) \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure (TVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI) \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Stroke (Ischemic and Hemorrhagic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Stroke (Ischemic and Hemorrhagic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Stroke (Ischemic and Hemorrhagic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Attainment of \\<30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Stroke (Ischemic and Hemorrhagic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Lesion Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Attainment of \\<30% final residual stenosis of the target lesion using any percutaneous method', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Attainment of \\<30% final residual stenosis of the target lesion and no in-hospital MACE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Bleeding or Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Bleeding Complications: Procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention Vascular Complications: May include pseudo aneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Early Stent Thrombosis (ARC Definition)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 30-days analysis (at least 23 days allowing for 7 days window) or patients who had an event within 30 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Late Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Stent Thrombosis after 30 days and on or before 180 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 180-days analysis (at least 150 days allowing for 30 days window) or patients who had an event within 180 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Late Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '270 days', 'description': 'Stent Thrombosis after 30 days and on or before 270 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 270-days analysis (at least 240 days allowing for 30 days window) or patients who had an event within 270 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Late Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '360 days', 'description': 'Stent Thrombosis after 30 days and on or before 360 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The denominator is comprised of all the patients who had enough follow-up for 360-days analysis (at least 330 days allowing for 30 days window) or patients who had an event within 360 days post-procedure. The number of events varies for each of the endpoints resulting in different denominators.'}, {'type': 'SECONDARY', 'title': 'Definite and Probable Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1800 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'KM analysis estimate for patients in the ITT population who had enough follow-up for 1800-days analysis (at least 1770 days allowing for 30 days window) or patients who had an event within 1800 days post-procedure and censoring those not reaching the endpoint or sufficient follow up.'}, {'type': 'SECONDARY', 'title': 'In-Segment Percent Diameter Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiographic Cohort', 'description': 'A group of patients who underwent angiographic assessment after the clinical assessment at 270 days.'}], 'classes': [{'title': 'In-Segment percent diameter stenosis (%DS)', 'categories': [{'measurements': [{'value': '38.34', 'spread': '17.03', 'groupId': 'OG000'}]}]}, {'title': 'In-Stent percent diameter stenosis (%DS)', 'categories': [{'measurements': [{'value': '36.89', 'spread': '18.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '270 days', 'description': 'Relative changes that occur in the percent diameter stenosis of the segment and are provided by the following relationship: % diameter stenosis= (1-\\[MLD/Reference diameter\\]) x 100', 'unitOfMeasure': 'percentage of vessel', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Angiographic subset included 115 of the 296 enrolled. Therefore, only 115 participants analyzed.'}, {'type': 'SECONDARY', 'title': 'In-Stent and In-Segment MLD and Late Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiographic Cohort', 'description': 'A group of patients who underwent an angiographic assessment after the clinical assessment at 270 days'}], 'classes': [{'title': 'In-Stent Late Loss', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'In-segment late loss', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.49', 'groupId': 'OG000'}]}]}, {'title': 'In-stent minimum lumen diameter', 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'In-segment minimum lumen diameter', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '270 days', 'description': '* In-stent and in-Segment minimal lumen diameter obtained immediately after stent implantation and at angiographic assessment at 270 days.\n* In-stent or in-segment late loss was defined as the difference between minimum lumen diameter (in-stent or in-segment) immediately after implantation and that obtained at angiographic follow-up at 270 days.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.'}, {'type': 'SECONDARY', 'title': 'Angiographic Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent'}], 'classes': [{'title': 'In-segment binary restenosis', 'categories': [{'measurements': [{'value': '28.57', 'groupId': 'OG000'}]}]}, {'title': 'In-stent binary angiographic restenosis', 'categories': [{'measurements': [{'value': '25.64', 'groupId': 'OG000'}]}]}, {'title': 'Stent fracture', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '270 days', 'description': 'Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'Angiographic subset of patients'}, {'type': 'SECONDARY', 'title': 'In-stent Neointimal Thickness (INT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT Cohort', 'description': 'A group of those patients who underwent OCT assessment after the clinical follow up at 270 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '270 days', 'description': 'in-stent neointimal thickness assessed by Optical Coherence Tomography', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OCT subset included 57 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 57.'}, {'type': 'SECONDARY', 'title': 'Percentage of Uncovered and/or Malapposed Struts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT Cohort', 'description': 'A group of those patients who underwent OCT assessment after the clinical follow up at 270 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '270 days', 'description': 'This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants', 'unitOfMeasure': '% of Uncovered and/or Malapposed Struts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OCT subset included 57 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 57.'}, {'type': 'SECONDARY', 'title': 'Lumen and Stent Area Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCT Cohort', 'description': 'A group of those patients who underwent OCT assessment after the clinical follow up at 270 days'}], 'classes': [{'title': 'Lumen Area', 'categories': [{'measurements': [{'value': '5.52', 'spread': '2.52', 'groupId': 'OG000'}]}]}, {'title': 'Stent Area', 'categories': [{'measurements': [{'value': '8.41', 'spread': '2.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '270 days', 'description': 'Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OCT subset included only 57 of the 296 participants enrolled. Therefore, only 57 participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Lumen and Stent Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent System'}], 'classes': [{'title': 'Lumen volume', 'categories': [{'measurements': [{'value': '97.44', 'spread': '61.27', 'groupId': 'OG000'}]}]}, {'title': 'Stent volume', 'categories': [{'measurements': [{'value': '149.06', 'spread': '75.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '270 days', 'description': 'Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days', 'unitOfMeasure': 'mm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OCT subset includes 57 of the 296 enrolled. Therefore, only 57 participants analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent System'}], 'periods': [{'title': '30 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '180 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': '270 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'There was a total of 296 patients enrolled on this study between August 2013 - February 2015. A total of 35 clinical sites contributed the 296 patients enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'COBRA PzF Stent', 'description': 'COBRA PzF Coronary Stent System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.46', 'spread': '10.29', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '208', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Latvia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.46', 'spread': '5.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent to Treat Population'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-21'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2017-01-30', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2013-08-09', 'dispFirstSubmitQcDate': '2017-01-30', 'resultsFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2013-08-16', 'dispFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-23', 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '270 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.'}], 'secondaryOutcomes': [{'measure': 'All Cause Mortality', 'timeFrame': '30 days', 'description': 'Death from any cause'}, {'measure': 'All Cause Mortality', 'timeFrame': '180 days', 'description': 'Death from any cause'}, {'measure': 'All Cause Mortality', 'timeFrame': '270 days', 'description': 'Death from any cause'}, {'measure': 'All Cause Mortality', 'timeFrame': '360 days', 'description': 'Death from any cause'}, {'measure': 'All Cause Mortality', 'timeFrame': '1800 days', 'description': 'Death from any cause'}, {'measure': 'Cardiac Mortality', 'timeFrame': '30 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded'}, {'measure': 'Cardiac Mortality', 'timeFrame': '180 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded'}, {'measure': 'Cardiac Mortality', 'timeFrame': '270 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded'}, {'measure': 'Cardiac Mortality', 'timeFrame': '360 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded'}, {'measure': 'Cardiac Mortality', 'timeFrame': '1800 days', 'description': 'Death due to any of the following:\n\nAcute myocardial infarction Cardiac perforation/pericardial tamponade Arrhythmia or conduction abnormality Cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure Death due to complication of a cardiac procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery Any death is which a cardiac cause cannot be excluded'}, {'measure': 'Major Adverse Cardiac Events (MACE)', 'timeFrame': '30 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods'}, {'measure': 'Major Adverse Cardiac Events (MACE)', 'timeFrame': '180 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods'}, {'measure': 'Major Adverse Cardiac Events (MACE)', 'timeFrame': '270 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods'}, {'measure': 'Major Adverse Cardiac Events (MACE)', 'timeFrame': '360 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods'}, {'measure': 'Major Adverse Cardiac Events (MACE)', 'timeFrame': '1800 days', 'description': 'Cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods'}, {'measure': 'Myocardial Infarction (MI-ARC Definition)', 'timeFrame': '30 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves (historical definition). ARC definition includes Troponin or CK-MB \\>3 x UNL'}, {'measure': 'Myocardial Infarction (MI-ARC Definition)', 'timeFrame': '180 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves'}, {'measure': 'Myocardial Infarction (MI-ARC Definition)', 'timeFrame': '270 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves'}, {'measure': 'Myocardial Infarction (MI-ARC Definition)', 'timeFrame': '360 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves'}, {'measure': 'Myocardial Infarction (MI-ARC Definition)', 'timeFrame': '1800 days', 'description': 'Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQMI). QWMI is defined as development of new, pathological Q waves in 2 or more contiguous leads (as assessed by the Clinical Events Committee) with post-procedure CK-MB levels elevated above normal.\n\nNQWMI is defined as any elevation of post-procedure CK-MB to \\>=3 times site normal in the absence of pathological Q waves'}, {'measure': 'Cardiac Death or MI (ARC Definition)', 'timeFrame': '30 days', 'description': 'Composite Endpoint of Cardiac Death or MI (ARC definition)'}, {'measure': 'Cardiac Death or MI (ARC Definition)', 'timeFrame': '180 days', 'description': 'Composite Endpoint of Cardiac Death and MI (ARC definition)'}, {'measure': 'Cardiac Death or MI (ARC Definition)', 'timeFrame': '270 days', 'description': 'Composite Endpoint of Cardiac Death or MI (ARC definition)'}, {'measure': 'Cardiac Death or MI (ARC Definition)', 'timeFrame': '360 days', 'description': 'Composite Endpoint of Cardiac Death or MI (ARC definition)'}, {'measure': 'Clinically Driven TLR', 'timeFrame': '30 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TLR', 'timeFrame': '180 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TLR', 'timeFrame': '270 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TLR (Clinical and Angiographic Cohorts)', 'timeFrame': '360 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TLR (Clinical Cohorts)', 'timeFrame': '360 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TLR (Clinical and Angiographic Cohorts)', 'timeFrame': '1800 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TLR (Clinical Cohorts)', 'timeFrame': '1800 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TVR', 'timeFrame': '30 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TVR', 'timeFrame': '180 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TVR', 'timeFrame': '270 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Clinically Driven TVR', 'timeFrame': '360 days', 'description': 'Defined as a percutaneous intervention or surgical bypass of any segment of the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \\>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '30 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI) \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.'}, {'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '180 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI) \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.'}, {'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '360 days', 'description': 'TVF defined as cardiac death, target vessel myocardial infarction (MI) \\[Q wave or non-Q wave, ARC definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods.'}, {'measure': 'Stroke (Ischemic and Hemorrhagic)', 'timeFrame': '30 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.'}, {'measure': 'Stroke (Ischemic and Hemorrhagic)', 'timeFrame': '180 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.'}, {'measure': 'Stroke (Ischemic and Hemorrhagic)', 'timeFrame': '270 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.'}, {'measure': 'Device Success', 'timeFrame': '30 days', 'description': 'Attainment of \\<30% final residual stenosis of the target lesion using only the COBRA PzF Coronary Stent System'}, {'measure': 'Stroke (Ischemic and Hemorrhagic)', 'timeFrame': '360 days', 'description': 'Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.'}, {'measure': 'Lesion Success', 'timeFrame': '30 days', 'description': 'Attainment of \\<30% final residual stenosis of the target lesion using any percutaneous method'}, {'measure': 'Procedure Success', 'timeFrame': '30 days', 'description': 'Attainment of \\<30% final residual stenosis of the target lesion and no in-hospital MACE'}, {'measure': 'Bleeding or Vascular Complications', 'timeFrame': '30 days', 'description': 'Bleeding Complications: Procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention Vascular Complications: May include pseudo aneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair'}, {'measure': 'Early Stent Thrombosis (ARC Definition)', 'timeFrame': '30 days', 'description': 'Early Stent Thrombosis (ARC Definition) 0-30 days post index procedure'}, {'measure': 'Late Stent Thrombosis', 'timeFrame': '180 days', 'description': 'Stent Thrombosis after 30 days and on or before 180 days'}, {'measure': 'Late Stent Thrombosis', 'timeFrame': '270 days', 'description': 'Stent Thrombosis after 30 days and on or before 270 days'}, {'measure': 'Late Stent Thrombosis', 'timeFrame': '360 days', 'description': 'Stent Thrombosis after 30 days and on or before 360 days'}, {'measure': 'Definite and Probable Stent Thrombosis', 'timeFrame': '1800 days', 'description': 'Defined as a percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis of \\>= 50% by QCA, or revascularization of a target vessel with a diameter stenosis of \\>=70% by QCA without either angina or a positive functional study.'}, {'measure': 'In-Segment Percent Diameter Stenosis', 'timeFrame': '270 days', 'description': 'Relative changes that occur in the percent diameter stenosis of the segment and are provided by the following relationship: % diameter stenosis= (1-\\[MLD/Reference diameter\\]) x 100'}, {'measure': 'In-Stent and In-Segment MLD and Late Loss', 'timeFrame': '270 days', 'description': '* In-stent and in-Segment minimal lumen diameter obtained immediately after stent implantation and at angiographic assessment at 270 days.\n* In-stent or in-segment late loss was defined as the difference between minimum lumen diameter (in-stent or in-segment) immediately after implantation and that obtained at angiographic follow-up at 270 days.'}, {'measure': 'Angiographic Endpoints', 'timeFrame': '270 days', 'description': 'Angiographic subset included 115 of the 296 enrolled. Therefore, the overall number of participants analyzed for this outcome measure is 115.'}, {'measure': 'In-stent Neointimal Thickness (INT)', 'timeFrame': '270 days', 'description': 'in-stent neointimal thickness assessed by Optical Coherence Tomography'}, {'measure': 'Percentage of Uncovered and/or Malapposed Struts', 'timeFrame': '270 days', 'description': 'This measure assess the average proportion of uncovered and or malapposed struts measured by Optical Coherence Tomography in participants'}, {'measure': 'Lumen and Stent Area Measurements', 'timeFrame': '270 days', 'description': 'Optical Coherence Tomography assessment of the lumen and stent area after the clinical follow up at 270 days'}, {'measure': 'Lumen and Stent Volume', 'timeFrame': '270 days', 'description': 'Optical Coherence Tomography assessment of the lumen and stent volume after the clinical follow up at 270 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stent, Coronary Arteries for Early healing'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.', 'detailedDescription': 'The main objective of this study is to evaluate the safety and effectiveness of the COBRA PzF™ Coronary Stent System in the treatment of de novo lesions in native coronary arteries. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the COBRA PzFTM Coronary Stent System. This rate will be compared to a performance goal derived using a meta-analysis from published historical data of the standard-of-care therapy, coronary stenting with bare metal stents.\n\nPRIMARY STUDY HYPOTHESIS The CeloNova COBRA PzFTM Study will have a primary endpoint (TVF) rate less than 19.62% and by that will meet the performance goal for bare metal stents, per the results of the historical control group combined with relevant data for EXPRESS™, Driver™, Presillion/Presillion plus™ and NIRFLEX™ stents.\n\nSECONDARY STUDY HYPOTHESIS The powered secondary endpoint for this trial is that the CeloNova COBRA PzFTM Study will have a 9-month in-stent late loss (LL) that meets or is lower than the performance goal of 1.1 mm.\n\nNUMBER OF PATIENTS 296 patients will be enrolled to account for loss to follow-up, which is estimated to be approximately 5% (resulting in 281 evaluable patients), at up to 40 sites in United States and OUS. At least 40% of subjects will be enrolled in the United States.\n\nPRIMARY ENDPOINT Target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) \\[Q wave or non-Q wave, ARC-definition\\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.\n\nSECONDARY ENDPOINTS\n\n1. All Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days\n2. Cardiac Death at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days\n3. Major Adverse Cardiac Events (MACE), defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days\n4. MI at 30, 180 and 270, 360, 720, 1080, 1440, and 1800 days CeloNova Biosciences, Inc. Confidential CeloNova COBRA PzF™ Study Protocol # COBRA 2012-01 6 07 May 14\n5. Clinically driven TLR at 30, 180, 270, 360, 720, 1080, 1440, and 1800 days\n6. Stroke (ischemic and hemorrhagic) at 30, 180, 270 and 360 days\n7. Clinically driven TVR at 30, 180, 270 and 360 days\n8. Composite Endpoint of Cardiac Death and MI at 30, 180, 270, and 360 days\n9. TVF at 30, 180, and 360 days\n10. Acute Success Rates\n\n 1. Device Success: Attainment of \\< 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System.\n 2. Lesion Success: Attainment of \\< 30% final residual stenosis of the target lesion using any percutaneous method.\n 3. Procedure Success: Attainment of \\< 30% final residual stenosis of the target lesion and no in-hospital MACE.\n11. Bleeding or Vascular Complications at hospital discharge\n12. Early Stent Thrombosis (ARC defined) at 30 days\n13. Late Stent Thrombosis at 180, 270, and 360 days\n14. Angiographic Endpoints (on first 90 evaluable patients) at 270 days (after clinical assessment)\n\n 1. In-stent late loss (Secondary Endpoint hypothesis)\n 2. In-segment percent diameter stenosis (%DS) (within the 5 mm margins proximal and distal to stent)\n 3. In-stent percent diameter stenosis (%DS)\n 4. In-segment late loss\n 5. In-segment binary restenosis (stenosis of \\> 50% of the reference vessel diameter)\n 6. In-stent binary restenosis\n 7. In-stent minimum lumen diameter (MLD)\n 8. In-segment MLD\n 9. Longitudinal stent deformation\n 10. Stent fracture\n15. Optical Coherence Tomography Endpoints (on 45 subjects) at 270 days (after clinical assessment)\n\n 1. in-stent neointimal thickness (NT)\n 2. Lumen area\n 3. Lumen volume\n 4. Stent area\n 5. Stent volume\n 6. Proportion of uncovered and/or malopposed struts\n 7. Stent fracture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "General Inclusion Criteria:\n\n1. Patient \\>/= to 18 years old.\n2. Eligible for percutaneous coronary intervention (PCI).\n3. Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.\n4. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.\n5. Acceptable candidate for coronary artery bypass graft (CABG) surgery.\n6. Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).\n7. Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).\n\nAngiographic Inclusion Criteria\n\n1. Patient indicated for elective stenting of a single stenotic lesion in a native coronary artery.\n2. Reference vessel \\>/= 2.5 mm and \\</= 4.0 mm in diameter by visual estimate.\n3. Target lesion \\</= 24 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length).\n4. Protected left main lesion with \\>50% stenosis.\n5. Target lesion stenosis \\>/= 70% and \\< 100% by visual estimate.\n6. Target lesion stenosis \\<70% who meet physiological criteria for revascularization (i.e. positive FFR).\n\nGeneral Exclusion Criteria:\n\n1. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.\n2. Previously enrolled in another stent trial within the prior 2 years.\n3. ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.\n4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.\n5. The patient requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.\n6. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).\n7. Previous drug eluting stent (DES) deployment anywhere in the target vessel.\n8. Any previous stent placement within 15 mm (proximal or distal) of the target lesion.\n9. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.\n10. Concurrent medical condition with a life expectancy of less than 12 months.\n11. Documented left ventricular ejection fraction (LVEF) \\< 30% within 12 months prior to enrollment.\n12. Patients with diagnosis of MI within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment\n13. Previous brachytherapy in the target vessel.\n14. History of cerebrovascular accident or transient ischemic attack in the last 6 months.\n15. Leukopenia (leukocytes \\< 3.5 x 10(9) / liter).\n16. Neutropenia (Absolute Neutrophil Count \\< 1000/mm3) \\</= 3 days prior to enrollment.\n17. Thrombocytopenia (platelets \\< 100,000/mm3) pre-procedure.\n18. Active peptic ulcer or active GI bleeding.\n19. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.\n20. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.\n21. Serum creatinine level \\> 2.0 mg/dl within 7 days prior to index procedure.\n22. Patients unable to tolerate dual anti-platelets therapy (DAPT) for one month post procedure.\n\nAngiographic Exclusion Criteria\n\n1. Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the LAD or Circumflex artery or a branch thereof).\n2. Target vessel with any lesions with greater than 50% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA.\n3. Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying \\> 50% of the true lumen diameter) at any time.\n4. Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).\n5. Target lesion with side branches \\> 2.0mm in diameter.\n6. Target vessel is excessively tortuous (two bends \\> 90˚ to reach the target lesion).\n7. Target lesion is severely calcified.\n8. TIMI flow 0 or 1\n9. Target lesion is in a bypass graft"}, 'identificationModule': {'nctId': 'NCT01925794', 'briefTitle': 'COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT', 'organization': {'class': 'INDUSTRY', 'fullName': 'CeloNova BioSciences, Inc.'}, 'officialTitle': 'COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy. The PzF Shield Trial', 'orgStudyIdInfo': {'id': 'COBRA 2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COBRA PzF Stent', 'description': 'Single Arm study', 'interventionNames': ['Device: COBRA PzF']}], 'interventions': [{'name': 'COBRA PzF', 'type': 'DEVICE', 'armGroupLabels': ['COBRA PzF Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93303', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Bakersfield Memorial Hospital', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mt Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Heart Center of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70445', 'city': 'Lacombe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Heart Hospital', 'geoPoint': {'lat': 30.31353, 'lon': -89.94313}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart & Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '13088', 'city': 'Liverpool', 'state': 'New York', 'country': 'United States', 'facility': "St Joseph's Hospital", 'geoPoint': {'lat': 43.10646, 'lon': -76.2177}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Cardiovascular Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Southern Oregon Cardiology', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'York General Hospital', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiology Consultants of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Plaza Medical Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Endovascular & Heart Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cardiovascular Consultants', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '23229', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cardiovascular Specialists', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '54401', 'city': 'Wausau', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aspirus Heart & Vascular Institute', 'geoPoint': {'lat': 44.95914, 'lon': -89.63012}}, {'zip': '13097', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Clinique Axium', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '84902', 'city': 'Avignon', 'country': 'France', 'facility': 'Hopital Henri Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '68000', 'city': 'Colmar', 'country': 'France', 'facility': 'Albert Schweitzer Hospital', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '68100', 'city': 'Mulhouse', 'country': 'France', 'facility': 'Clinique du Diaconat', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '64046', 'city': 'Pau', 'country': 'France', 'facility': 'Centre Hospitalier de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '76600', 'city': 'Rouen', 'country': 'France', 'facility': 'Clinique St. Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '60389', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Sankt Kathatinen Hospital', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '81379', 'city': 'München', 'country': 'Germany', 'facility': 'Kardiologische Praxis und Praxisklinik', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '2166', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Paul Stradins Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CH-9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Donald Cutlip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Executive Director, Clinical Investigation, Harvard Clinical Research Institute'}, {'name': 'Sigmund Sliber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine at The University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CeloNova BioSciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}