Viewing Study NCT00941733

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Ignite Creation Date: 2025-12-25 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 5:49 PM
Study NCT ID: NCT00941733
Status: COMPLETED
Last Update Posted: 2018-02-28
First Post: 2009-07-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kristel.wittebols@medtronic.com', 'phone': '+31433566580', 'title': 'Clinical Research Director', 'organization': 'Medtronic - CardioVascular'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty', 'otherNumAtRisk': 239, 'otherNumAffected': 220, 'seriousNumAtRisk': 239, 'seriousNumAffected': 197}, {'id': 'EG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty', 'otherNumAtRisk': 119, 'otherNumAffected': 108, 'seriousNumAtRisk': 119, 'seriousNumAffected': 92}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephrogenic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetic retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyalosis asteroid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophagitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, 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'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tracheostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial stenosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 28, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Necrosis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 64, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 59, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Reperfusion injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '0.605', 'spread': '0,775', 'groupId': 'OG000'}, {'value': '0.616', 'spread': '0.781', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months or at Target Lesion Revascularization (TLR) time', 'description': 'The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Amputation free surviving meaning participants without an amputation at 12 months. This analysis population consists of 196 participants in the Drug Eluting Balloon arm and 107 participants in the Standard PTA arm.'}, {'type': 'PRIMARY', 'title': 'Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '17.67', 'groupId': 'OG000'}, {'value': '15.79', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage based on number of evaluable subjects for safety events (232 participants in the drug eluting balloon arm and 114 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.'}, {'type': 'SECONDARY', 'title': 'Amputation Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}, {'value': '89.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with a 1 year amputation free survival.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.'}, {'type': 'SECONDARY', 'title': 'Rate of Wound Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000'}, {'value': '76.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of \\> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.', 'unitOfMeasure': 'percentage of patients analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with pre-existing wounds and/or occurence of new wounds'}, {'type': 'SECONDARY', 'title': 'Amputation Free Survival and Wound Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000'}, {'value': '68.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of \\> 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage based on number of evaluable subjects for safety events (206 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.'}, {'type': 'SECONDARY', 'title': 'Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '66.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage based on number of evaluable subjects for safety events (205 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.'}, {'type': 'SECONDARY', 'title': 'Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.'}, {'type': 'SECONDARY', 'title': 'Primary Sustained Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000'}, {'value': '68.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects'}, {'type': 'SECONDARY', 'title': 'Secondary Sustained Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000'}, {'value': '78.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessment by EQ5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6975', 'spread': '0.3080', 'groupId': 'OG000'}, {'value': '0.7445', 'spread': '0.3035', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.\n\nEQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Analysis sets - all randomized subjects with available data for EQ5D at baseline and 1 year'}, {'type': 'SECONDARY', 'title': 'Walking Capacity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '75.4', 'spread': '31.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.\n\nA WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) - 100 (maximum).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Effectiveness Analysis sets - all randomized subjects with available data for Walking Impairment assessment at baseline and 1 year'}, {'type': 'SECONDARY', 'title': 'MAE (Major Adverse Events)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '25.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}, {'value': '96.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities', 'unitOfMeasure': 'percentage of device deployments', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of device deployments'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}, {'value': '88.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography', 'unitOfMeasure': 'percentage of device deployments', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of device deployments'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with available data'}, {'type': 'SECONDARY', 'title': 'Days of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Days of hospitalization at 1 year', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with available data'}, {'type': 'SECONDARY', 'title': 'Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'OG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'Angiographic subgroup only. Angio-target lesion is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis higher than 70% and a cumulative length less than 100 mm that can be covered by a single IN.PACT Amphirion™; and Angio-target lesion is the only lesion in that vessel.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'FG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '1 year follow-up', 'groupId': 'FG000', 'numSubjects': '165'}, {'comment': '1 year follow-up', 'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug Eluting Balloon', 'description': 'IN.PACT Amphirion: Balloon Angioplasty'}, {'id': 'BG001', 'title': 'Standard PTA', 'description': 'Standard PTA balloon: Balloon Angioplasty'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '71.7', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '72.5', 'spread': '9.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The total sample size for the study was planned to be 357 subjects, which was intended to fully power the trial for the endpoints of LLL and the composite safety endpoint based on initial estimates of event rates and effect sizes. The endpoint of 12-month TLR was powered to 65% with the indicated sample size.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2009-07-16', 'resultsFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-24', 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)', 'timeFrame': '12 months or at Target Lesion Revascularization (TLR) time', 'description': 'The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up'}, {'measure': 'Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients', 'timeFrame': '12 months', 'description': 'Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).'}, {'measure': 'Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)', 'timeFrame': '6 months', 'description': 'Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)'}], 'secondaryOutcomes': [{'measure': 'Amputation Free Survival', 'timeFrame': '12 months', 'description': 'Percentage of participants with a 1 year amputation free survival.'}, {'measure': 'Rate of Wound Healing', 'timeFrame': '12 months', 'description': 'Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of \\> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.'}, {'measure': 'Amputation Free Survival and Wound Healing', 'timeFrame': '12 months', 'description': 'Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of \\> 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.'}, {'measure': 'Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)', 'timeFrame': '12 months', 'description': 'Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.'}, {'measure': 'Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)', 'timeFrame': '12 months', 'description': 'Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.'}, {'measure': 'Primary Sustained Clinical Improvement', 'timeFrame': '12 months', 'description': 'Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.'}, {'measure': 'Secondary Sustained Clinical Improvement', 'timeFrame': '12 months', 'description': 'Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.'}, {'measure': 'Quality of Life Assessment by EQ5D', 'timeFrame': '12 months', 'description': "Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.\n\nEQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'."}, {'measure': 'Walking Capacity Assessment', 'timeFrame': '12 months', 'description': 'Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.\n\nA WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) - 100 (maximum).'}, {'measure': 'MAE (Major Adverse Events)', 'timeFrame': '12 months', 'description': 'Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb'}, {'measure': 'Device Success', 'timeFrame': 'Day 1', 'description': 'Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities'}, {'measure': 'Technical Success', 'timeFrame': 'Day 1', 'description': 'Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography'}, {'measure': 'Procedural Success', 'timeFrame': 'Day 1', 'description': 'Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications'}, {'measure': 'Days of Hospitalization', 'timeFrame': '12 months', 'description': 'Days of hospitalization at 1 year'}, {'measure': 'Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)', 'timeFrame': '12 months', 'description': 'Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BTK', 'CLI', 'PTA'], 'conditions': ['Critical Lower Limb Ischemia']}, 'referencesModule': {'references': [{'pmid': '32081236', 'type': 'DERIVED', 'citation': 'Zeller T, Micari A, Scheinert D, Baumgartner I, Bosiers M, Vermassen FEG, Banyai M, Shishehbor MH, Wang H, Brodmann M; IN.PACT DEEP Trial Investigators. The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes. JACC Cardiovasc Interv. 2020 Feb 24;13(4):431-443. doi: 10.1016/j.jcin.2019.10.059.'}, {'pmid': '25301459', 'type': 'DERIVED', 'citation': 'Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha-Singh KJ; IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76. doi: 10.1016/j.jacc.2014.06.1198.'}, {'pmid': '24552184', 'type': 'DERIVED', 'citation': 'Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M; IN.PACT DEEP Trial Investigators. IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials. 2014 Feb 19;15:63. doi: 10.1186/1745-6215-15-63.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/24552184', 'label': 'Zeller et al. Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapoplliteal Arterial Revascularization in CLI - 12-Month Results from the IN.PACT DEEP Randomized trial.Journal of the American College of Cardiology 2014; 64; 15'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n* Age ≥18 years and ≤85 years\n* Patient or patient\'s legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form\n* Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation\n* Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6\n* Life expectancy \\>1 year in the Investigator\'s opinion\n\nGeneral Angiographic Inclusion Criteria\n\n* Reference vessel(s) diameter between 2 and 4 mm\n* Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main afferent crural vessels including the tibioperoneal trunk\n* At least one non occluded crural vessel with angiographically documented run-off to the foot either direct or through collaterals\n\nAngiographic Inclusion Criteria for Late Lumen Loss (LLL) assessment\n\n* Angio-target lesion (TL) is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis (DS) ≥70% and a cumulative length ≤100 mm that can be covered by a single IN.PACT Amphirion™ (10 mm balloon landing zone in both edges is mandatory)\n* Angio-target lesion (TL) is the only lesion in that vessel (only one Angio-TL per patient is allowed)\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n* Patient unwilling or unlikely to comply with Follow-Up schedule\n* Planned major index limb amputation\n\nGeneral Angiographic Exclusion Criteria\n\n* Lesion and / or occlusions located or extending in the popliteal artery or below the ankle joint space\n* Inflow lesion or occlusion in the ipsilateral Iliac, Superficial Femoral Artery (SFA), popliteal arteries with length ≥15 cm\n* Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral Iliac, Superficial Femoral Artery (SFA) and popliteal arteries left untreated\n* Previously implanted stent in the target lesions(s)\n* Aneurysm in the target vessel\n* Acute thrombus in the target limb\n\nGeneral Procedural Exclusion Criteria\n\n* Failure to obtain a \\<30% residual stenosis in pre-existing, hemodynamically significant (≥50% diameter stenosis (DS) and \\<15 cm length) inflow lesions in the ipsilateral iliac, SFA and popliteal artery. No Drug Eluting Stents (DES) and / or Drug Eluting Balloon (DEB) allowed for the treatment of inflow lesions.\n* Failure to cross the TL with a 0.014" guide wire\n* Use of alternative therapy, e.g. atherectomy, cutting balloon, laser, radiation therapy, DES as part of the index procedure\n\nANGIOGRAPHIC cohort General Exclusion Criteria:\n\n\\- Glomerular Filtration Rate (GFR) \\<30 ml/min except for patients with renal end stage disease on chronic haemodialysis'}, 'identificationModule': {'nctId': 'NCT00941733', 'acronym': 'INPACT-DEEP', 'briefTitle': 'Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia', 'orgStudyIdInfo': {'id': 'P998'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug Eluting Balloon', 'description': 'Intervention: IN.PACT Amphirion™', 'interventionNames': ['Device: IN.PACT Amphirion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard PTA', 'description': 'Intervention: Standard PTA', 'interventionNames': ['Device: Standard PTA']}], 'interventions': [{'name': 'IN.PACT Amphirion', 'type': 'DEVICE', 'description': 'Balloon Angioplasty', 'armGroupLabels': ['Drug Eluting Balloon']}, {'name': 'Standard PTA', 'type': 'DEVICE', 'description': 'Balloon Angioplasty', 'armGroupLabels': ['Standard PTA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Hospital', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'AZ Sint-Blasius', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'ZOL St. Jan', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herz-Zentrum Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Medical Care Center', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Park-Krankenhaus Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Villa Maria Eleonora Hospital', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Lucerne', 'country': 'Switzerland', 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'overallOfficials': [{'name': 'Dierk Scheinert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Leipzig - University Hospital'}, {'name': 'Thomas Zeller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heart Center Freiburg - Bad Krozingen'}, {'name': 'Iris Baumgartner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}