Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-04-12 @ 5:30 PM
Study NCT ID:
NCT02400905
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2015-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nick.yeo@veryanmed.com', 'phone': '+44 1403 258984', 'title': 'Nick Yeo', 'organization': 'Veryan Medical'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '36 months', 'description': 'Site reported serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 177, 'seriousNumAtRisk': 271, 'deathsNumAffected': 24, 'seriousNumAffected': 164}], 'otherEvents': [{'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial stenosis (non-target)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 68, 'numAffected': 50}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restenosis of treated segment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 77, 'numAffected': 63}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restenosis of treated vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular access complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Restenosis of treated segment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 60, 'numAffected': 47}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial stenosis (non-target)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 51, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restenosis of treated vessel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abrupt occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amputation (unplanned, spontaneous)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dissection (≥ Grade C) in target vessel requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Embolization, distal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Total occlusion of the peripheral artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive heart failure (CHF)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastro-intestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected peripheral wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection (UTI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial occlusion/thrombus at puncture site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular access complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin hematoma ≥ 5 cm, with or without surgical repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke or other neurological complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure/renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction (medication, contrast media, device, etc.)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amputation (planned)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding from anticoagulant or antiplatelet medications s', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhage, with or without transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death (MAE if cardiovascular-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemic attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 172, 'numAffected': 95}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with available 30 day follow-up'}, {'type': 'PRIMARY', 'title': 'Primary Effectiveness Endpoint (Primary Stent Patency Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The primary effectiveness endpoint of the MIMICS-2 Study was defined as the primary stent patency rate at 12 months. Patency was defined as no significant reduction in luminal diameter (\\< 50% diameter stenosis) since the index procedure. Loss of patency was determined by an independent core laboratory when the peak systolic velocity ratio (PSVR) exceeds 2.0, or where angiography revealed \\> 50% diameter stenosis, or where the subject had a CDTLR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were included in analysis population if they had imaging data qualifying as a 12m visit and/or subjects without imaging data who experienced a CDTLR through 12 months. Additionally, if a subject is missing stent patency status at the 12m window but found to be patent at a later out-of-window date, subject was considered patent at 12 months'}, {'type': 'SECONDARY', 'title': 'Secondary Safety (Overall MAE Rate at 30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'classes': [{'title': 'Freedom from Death', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Major Amputation', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from CD-TLR', 'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with available 30 day follow-up'}, {'type': 'SECONDARY', 'title': 'Long Term Safety (Overall MAE Rate at Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'classes': [{'title': 'Freedom from MAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from Major Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from CD-TLR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects are included in the analysis population if (i) they have sufficient follow-up (at least 12 months less 30 days), or (ii) they have had the event of interest (each event is considered separately).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'classes': [{'title': 'total number of participants', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}]}]}, {'title': 'All SAE (In-hospital)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'All SAE (30 Days)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'All SAE (12 Months)', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'All SAE (24 Months)', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}]}]}, {'title': 'All SAE (36 Months)', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Months', 'description': 'Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedural (at end of index procedure)', 'description': 'Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with available baseline angiography'}, {'type': 'SECONDARY', 'title': 'Primary Stent Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System\n\nBioMimics 3D Stent System: Femoropopliteal stenting'}], 'timeFrame': 'Months 12 & 24', 'description': 'Determined at Months-12 and 24 using values of: PSVR \\>2.0, \\>2.4; \\>2.5; and \\>3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals \\>50% diameter stenosis or where the subject undergoes clinically-driven TLR.\n\nFurther analysis of the patency data purely using a reference PSVR of \\>2.4, \\>2.5 and \\>3.5 was not feasible from the data that was collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Relevant data was not collected to provide the outcome analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement of Rutherford Clinical Category by 1 or More', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System\n\nBioMimics 3D Stent System: Femoropopliteal stenting'}], 'classes': [{'title': 'Improvement of Rutherford Category of 1 or more at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}]}]}, {'title': 'Improvement of Rutherford Category of 1 or more at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}, {'title': 'Improvement of Rutherford Category of 1 or more at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.\n\nCategories 0 - Asymptomatic\n\n1. \\- Mild claudication\n2. \\- Moderate claudication\n3. \\- Severe claudication\n4. \\- Ischemic rest pain\n5. \\- Minor tissue loss\n6. \\- Major tissue loss', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants participating in the study changed at 30 Days, 12 Months and 24 Months'}, {'type': 'SECONDARY', 'title': 'Clinical Outcome (Six-Minute Walk Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System\n\nBioMimics 3D Stent System: Femoropopliteal stenting'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '230', 'spread': '162', 'groupId': 'OG000'}]}]}, {'title': '30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '349', 'spread': '221', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '278', 'spread': '143', 'groupId': 'OG000'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '405', 'spread': '140', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).', 'unitOfMeasure': 'yards', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analysed changed over the time period'}, {'type': 'SECONDARY', 'title': 'Functional Outcome (Ankle Brachial Index (ABI) Measurement)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System\n\nBioMimics 3D Stent System: Femoropopliteal stenting'}], 'classes': [{'title': 'ABI at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'ABI at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'ABI at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'ABI at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.', 'unitOfMeasure': 'ABI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants assessed for ABI index measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.'}, {'type': 'SECONDARY', 'title': 'Change of Walking Impairment Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System\n\nBioMimics 3D Stent System: Femoropopliteal stenting'}], 'classes': [{'title': 'Baseline WIQ score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': '30 Days WIQ score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': '12 Months WIQ score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': '24 Months WIQ score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.\n\nThe WIQ consists of 3 primary categories assessing walking distance, stair-climbing, and walking speed, as previously described. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (unable) to 4 (none).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Walking Impairment Questionnaire score at Baseline, within 30 days after index procedure, then at Months 12 and 24.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Freedom From Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System\n\nBioMimics 3D Stent System: Femoropopliteal stenting'}], 'classes': [{'title': 'Freedom from stent fracture at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from stent fracture at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'Freedom from stent fracture at 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 12, 24 & 36', 'description': 'Stent integrity measured as freedom from fracture, defined as clear interruption of a stent strut observed in a minimum of two projections, determined by core lab examination of X-rays taken with the leg in extension at 12, 24 and 36 Months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with no fracture in study stent at 12, 24 and 36 Months assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}]}, {'type': '30-Days Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}]}, {'type': '12-Months Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}]}, {'type': '24-Months Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}]}, {'type': '36 Months-Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BioMimics 3D Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '253', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '215', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-20', 'size': 1437073, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-05T08:36', 'hasProtocol': True}, {'date': '2018-04-25', 'size': 624357, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-05T08:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2015-03-23', 'resultsFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-21', 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)', 'timeFrame': '30 days', 'description': 'Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.'}, {'measure': 'Primary Effectiveness Endpoint (Primary Stent Patency Rate)', 'timeFrame': '12 months', 'description': 'The primary effectiveness endpoint of the MIMICS-2 Study was defined as the primary stent patency rate at 12 months. Patency was defined as no significant reduction in luminal diameter (\\< 50% diameter stenosis) since the index procedure. Loss of patency was determined by an independent core laboratory when the peak systolic velocity ratio (PSVR) exceeds 2.0, or where angiography revealed \\> 50% diameter stenosis, or where the subject had a CDTLR.'}], 'secondaryOutcomes': [{'measure': 'Secondary Safety (Overall MAE Rate at 30 Days)', 'timeFrame': '30 Days', 'description': 'Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.'}, {'measure': 'Long Term Safety (Overall MAE Rate at Month 12)', 'timeFrame': '12 months', 'description': 'Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.'}, {'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': '36 Months', 'description': 'Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.'}, {'measure': 'Technical Success', 'timeFrame': 'Procedural (at end of index procedure)', 'description': 'Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure'}, {'measure': 'Primary Stent Patency', 'timeFrame': 'Months 12 & 24', 'description': 'Determined at Months-12 and 24 using values of: PSVR \\>2.0, \\>2.4; \\>2.5; and \\>3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals \\>50% diameter stenosis or where the subject undergoes clinically-driven TLR.\n\nFurther analysis of the patency data purely using a reference PSVR of \\>2.4, \\>2.5 and \\>3.5 was not feasible from the data that was collected.'}, {'measure': 'Number of Participants With Improvement of Rutherford Clinical Category by 1 or More', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.\n\nCategories 0 - Asymptomatic\n\n1. \\- Mild claudication\n2. \\- Moderate claudication\n3. \\- Severe claudication\n4. \\- Ischemic rest pain\n5. \\- Minor tissue loss\n6. \\- Major tissue loss'}, {'measure': 'Clinical Outcome (Six-Minute Walk Test)', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).'}, {'measure': 'Functional Outcome (Ankle Brachial Index (ABI) Measurement)', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.'}, {'measure': 'Change of Walking Impairment Questionnaire Score', 'timeFrame': 'Baseline, Day 30, Months 12 & 24', 'description': 'Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.\n\nThe WIQ consists of 3 primary categories assessing walking distance, stair-climbing, and walking speed, as previously described. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (unable) to 4 (none).'}, {'measure': 'Number of Participants With Freedom From Stent Fracture', 'timeFrame': 'Months 12, 24 & 36', 'description': 'Stent integrity measured as freedom from fracture, defined as clear interruption of a stent strut observed in a minimum of two projections, determined by core lab examination of X-rays taken with the leg in extension at 12, 24 and 36 Months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PAD', 'PVD', 'SFA stent'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '33331207', 'type': 'DERIVED', 'citation': 'Sullivan TM, Zeller T, Nakamura M, Gaines PA; MIMICS-2 Trial Investigators. Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial. J Endovasc Ther. 2021 Apr;28(2):236-245. doi: 10.1177/1526602820980419. Epub 2020 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.', 'detailedDescription': 'The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility criteria may be considered for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion of the native femoropopliteal artery.\n* PAD classified as Rutherford clinical category 2, 3 or 4.\n* Resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target limb) or angiographic or DUS evidence of \\>/= 60%.\n* Single or multiple stenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.\n* Single or multiple target lesions must be covered by a single stent or two overlapping stents.\n* Target lesion(s) eligible for treatment at least 1 cm distal to the origin of the deep femoral artery and at least 3 cm above the bottom of the femur.\n* Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm.\n* Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with ≥60% diameter stenosis by operator\'s visual estimate.\n* Patent popliteal artery (no stenosis ≥50%) distal to the treated segment.\n* At least one patent infrapopliteal vessel (\\<50% stenosis) with run-off to the ankle.\n\nExclusion Criteria:\n\n* Iliac stent in target limb that has required re-intervention within 12 months prior to index.\n* Target vessel that has been treated with bypass surgery.\n* PAD classified as Rutherford clinical category 0, 1, 5 or 6.\n* Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR \\>1.8.\n* Stroke diagnosis within 3 months prior to enrollment.\n* History of unstable angina or myocardial infarction within 60 days prior to enrollment.\n* Thrombolysis within 72 hours prior to the index procedure.\n* Acute or chronic renal disease (e.g., as measured by a serum creatinine of \\>2.5 mg/dL or \\>220 umol/L), or on peritoneal or hemodialysis.\n* Significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication).\n* No patent (≥50% stenosis) outflow vessel providing run-off to the ankle.\n* Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stent.'}, 'identificationModule': {'nctId': 'NCT02400905', 'acronym': 'MIMICS-2', 'briefTitle': 'Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Veryan Medical Ltd.'}, 'officialTitle': 'MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'CID-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioMimics 3D Vascular Stent', 'description': 'Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System', 'interventionNames': ['Device: BioMimics 3D Vascular Stent System']}], 'interventions': [{'name': 'BioMimics 3D Vascular Stent System', 'type': 'DEVICE', 'description': 'Femoropopliteal stenting', 'armGroupLabels': ['BioMimics 3D Vascular Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Brookwood Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36532', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiology Associates of Mobile', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bradenton Cardiology Center', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'MediQuest Research Group/ Munroe Regional Medical Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Vascular', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF St. Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Education and Research Cooperative', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '41101', 'city': 'Ashland', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kings Daughters Medical Center', 'geoPoint': {'lat': 38.47841, 'lon': -82.63794}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Endovascular Technologies / Grace Research', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Outpatient Vascular Institute', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Hospital & Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48507', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Vascular Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart & Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '27067', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Heart & Vascular Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'WakeMed Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Methodist Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Doylestown Hospital', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '17043', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Harrisburg', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Berks Cardiologists', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '57018', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'North Central Heart', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Kore Cardiovascular Research', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Heart Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiovascular Specialist of TX / North Austin Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77340', 'city': 'Huntsville', 'state': 'Texas', 'country': 'United States', 'facility': 'Grace Research', 'geoPoint': {'lat': 30.72353, 'lon': -95.55078}}, {'zip': '78130', 'city': 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