Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT01154751
Status:
TERMINATED
Last Update Posted:
2017-09-19
First Post:
2010-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'margo.zaugg@av.abbott.com', 'phone': '408-845-0576', 'title': 'Margo Zaugg', 'organization': 'Abbott Vascular'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area', 'otherNumAtRisk': 109, 'otherNumAffected': 87, 'seriousNumAtRisk': 109, 'seriousNumAffected': 84}], 'otherEvents': [{'term': 'Hospital readmittance', 'notes': 'Hospital Readmittance:\n\nDevice-related readmittance to a care facility for a continuous period of 3 days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 28, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}, {'term': 'Death', 'notes': 'Death:\n\nAll-cause mortality.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 206, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}], 'seriousEvents': [{'term': 'Hospital readmittance', 'notes': 'Hospital Readmittance:\n\nDevice-related readmittance to a care facility for a continuous period of 3 days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 28, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}, {'term': 'Death', 'notes': 'Death:\n\nAll-cause mortality.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}, {'term': 'Amputation', 'notes': 'Amputation:\n\nAll-cause limb amputation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}, {'term': 'Bleeding', 'notes': 'After the perioperative period, an episode of internal or external bleeding that causes death, hospitalization, and permanent injury or necessitates transfusion of \\>20 cc/kg of body weight packed red blood cells in a 24-h period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 178, 'numAffected': 78}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Abbott categories'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Six-minute Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '171.30', 'spread': '85.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'PRIMARY', 'title': 'Six-minute Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '251.77', 'spread': '119.44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'PRIMARY', 'title': 'Six-minute Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '263.74', 'spread': '152.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'PRIMARY', 'title': 'Six-minute Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '262.19', 'spread': '141.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Peri-procedural and Post-procedural Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'title': 'At least one', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'AV fistula / pseudoaneurysm', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Subacute occlusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Peri-procedural and Post-procedural Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'title': 'At least one', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'AV fistula / pseudoaneurysm', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Subacute occlusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.', 'unitOfMeasure': 'Number of compilcations', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rutherford-Becker Clinical Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'title': '0 = Asymptomatic', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}]}]}, {'title': '1 = Mild claudication', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}]}]}, {'title': '2 = Moderate claudication', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}]}]}, {'title': '3 = Severe claudication', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}]}]}, {'title': '4 = Ischemic rest pain', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': '5 = Minor tissue loss', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}]}]}, {'title': '6 = Ulceration or gangrene', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Rutherford/Becker Categories:\n\n0 - Asymptomatic, no hemodynamically significant occlusive disease.\n\n1. \\- Mild claudication.\n2. \\- Moderate claudication.\n3. \\- Severe claudication.\n4. \\- Ischemic rest pain.\n5. \\- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.\n6. \\- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Restenosis by Duplex Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'title': 'PSVR ≥ 2.4', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'PSVR ≥ 2.5', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.\n\nThe number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Restenosis by Duplex Ultrasound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'title': 'PSVR ≥ 2.4', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}]}]}, {'title': 'PSVR ≥ 2.5', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.\n\nThe number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.\n\nTarget Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Stent fractures determined by fluoroscopy .', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 to 2 years', 'description': 'Stent fracture and Involuntary stent migration are types of device System Failure.\n\nDevice System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Stent Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 to 3 Years', 'description': 'Stent fracture and Involuntary stent migration are types of device System Failure.\n\nDevice System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Target Limb Ankle Brachial Index (at Rest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Target Limb Ankle Brachial Index (at Rest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '0.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Target Limb Ankle Brachial Index (at Rest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'spread': '0.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Target Limb Ankle Brachial Index (at Rest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '0.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Target Limb Ankle Brachial Index (at Rest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '0.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Years', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}, {'type': 'SECONDARY', 'title': 'Six-minute Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'classes': [{'categories': [{'measurements': [{'value': '272.75', 'spread': '152.80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Years', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed is based on the data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'periods': [{'title': '6-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}, {'title': '1-year Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': '2-year Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}, {'title': '3-year Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}]}], 'recruitmentDetails': 'This study planned to recruit up to 200 patients across 5-10 sites in the European Union. However, during the course of the study, intake was halted at 109 patients and the registry was terminated early because of slow enrollment, increased loss to follow-ups, and general lack of interest.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System\n\nSUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lesion length', 'classes': [{'title': 'Superficial femoral (n=86)', 'categories': [{'measurements': [{'value': '16.40', 'spread': '28.93', 'groupId': 'BG000'}]}]}, {'title': 'Popliteal (n=22)', 'categories': [{'measurements': [{'value': '7.77', 'spread': '5.00', 'groupId': 'BG000'}]}]}, {'title': 'Femoropopliteal conjunction (n=3)', 'categories': [{'measurements': [{'value': '18.67', 'spread': '2.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Lesion length is site reported', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent diameter stenosis', 'classes': [{'title': 'Superficial femoral (n=87)', 'categories': [{'measurements': [{'value': '93.07', 'spread': '8.78', 'groupId': 'BG000'}]}]}, {'title': 'Popliteal (n=23)', 'categories': [{'measurements': [{'value': '93.83', 'spread': '7.91', 'groupId': 'BG000'}]}]}, {'title': 'Femoropopliteal conjunction (n=3)', 'categories': [{'measurements': [{'value': '96.67', 'spread': '5.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Percent diameter stenosis is site reported.', 'unitOfMeasure': 'percentage diameter stenosis', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Occlusion', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Core laboratory reported', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'whyStopped': 'Slow enrollment,increased loss to follow-ups and general lack of interest.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2010-06-29', 'resultsFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-16', 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six-minute Walking Distance', 'timeFrame': 'At baseline', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.'}, {'measure': 'Six-minute Walking Distance', 'timeFrame': '30 days', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.'}, {'measure': 'Six-minute Walking Distance', 'timeFrame': '6 months', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.'}, {'measure': 'Six-minute Walking Distance', 'timeFrame': '1 Year', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Peri-procedural and Post-procedural Complications', 'timeFrame': '30 days', 'description': 'Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.'}, {'measure': 'Number of Peri-procedural and Post-procedural Complications', 'timeFrame': '30 days', 'description': 'Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.'}, {'measure': 'Rutherford-Becker Clinical Category', 'timeFrame': '30 days', 'description': 'Rutherford/Becker Categories:\n\n0 - Asymptomatic, no hemodynamically significant occlusive disease.\n\n1. \\- Mild claudication.\n2. \\- Moderate claudication.\n3. \\- Severe claudication.\n4. \\- Ischemic rest pain.\n5. \\- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.\n6. \\- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.'}, {'measure': 'Restenosis by Duplex Ultrasound', 'timeFrame': '6 months', 'description': 'In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.'}, {'measure': 'Restenosis by Duplex Ultrasound', 'timeFrame': '1 Year', 'description': 'In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.'}, {'measure': 'Target Lesion Revascularization', 'timeFrame': '6 months', 'description': 'Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).'}, {'measure': 'Target Lesion Revascularization', 'timeFrame': '1 Year', 'description': 'Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.\n\nTarget Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)'}, {'measure': 'Stent Fracture', 'timeFrame': '1 Year', 'description': 'Stent fractures determined by fluoroscopy .'}, {'measure': 'Stent Fracture', 'timeFrame': '1 to 2 years', 'description': 'Stent fracture and Involuntary stent migration are types of device System Failure.\n\nDevice System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.'}, {'measure': 'Stent Fracture', 'timeFrame': '1 to 3 Years', 'description': 'Stent fracture and Involuntary stent migration are types of device System Failure.\n\nDevice System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.'}, {'measure': 'Target Limb Ankle Brachial Index (at Rest)', 'timeFrame': 'At baseline', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.'}, {'measure': 'Target Limb Ankle Brachial Index (at Rest)', 'timeFrame': '30 days', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.'}, {'measure': 'Target Limb Ankle Brachial Index (at Rest)', 'timeFrame': '6 months', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.'}, {'measure': 'Target Limb Ankle Brachial Index (at Rest)', 'timeFrame': '1 Year', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.'}, {'measure': 'Target Limb Ankle Brachial Index (at Rest)', 'timeFrame': '2 Years', 'description': 'Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.\n\nABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure\n\nThe ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.'}, {'measure': 'Six-minute Walking Distance', 'timeFrame': '2 Years', 'description': 'The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Femoral artery stenosis', 'Peripheral vascular Disease'], 'conditions': ['Peripheral Artery Disease', 'Femoropopliteal Artery Stenosis', 'Peripheral Vascular Disease']}, 'descriptionModule': {'briefSummary': 'Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.', 'detailedDescription': 'This registry follows up to 200 patients for at least 5 years.\n\nThe STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\n(Clinical)\n\n* Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).\n* Rutherford-Becker classification 2 through 5 only\n* Patient is at least 18 years of age and of legal age of consent.\n* Patient must be willing to participate in the registry for at least 5 years.\n\n(Angiographic)\n\n* Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion\n* All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.\n* All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.\n* Target lesion length 1-20 cm (visual estimate)\n* Target lesion stenosis ≥50% (visual estimate)\n* Popliteal artery patent if the lesion is in the SFA\n* SFA patent if the lesion is in the popliteal artery\n* At least one widely patent (\\< 50% stenosis) infrapopliteal artery (for distal run-off)\n\nExclusion Criteria:\n\n(Clinical)\n\n* Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities\n* Patient is participating in a clinical study that could confound results\n* Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.\n\n(Angiographic)\n\n* Target lesion length \\> 20 cm\n* Instent restenotic / reoccluded target lesion\n* Acute (≤ 4 weeks) thrombotic occlusion\n* Untreated ipsilateral pelvic stenosis'}, 'identificationModule': {'nctId': 'NCT01154751', 'acronym': 'STRONG', 'briefTitle': 'Data Registry Following Patients Using Supera Stent in the Femoral Arteries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Supera Treatment Registry Observing Neointimal Growth', 'orgStudyIdInfo': {'id': 'IDEV Technologies, Inc.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Device SUPERA Stent', 'description': 'SUPERA Interwoven Self-Expanding Nitinol Stent System', 'interventionNames': ['Device: SUPERA Interwoven self-expanding nitinol stent']}], 'interventions': [{'name': 'SUPERA Interwoven self-expanding nitinol stent', 'type': 'DEVICE', 'description': 'Insertion of stent at stenotic area', 'armGroupLabels': ['Device SUPERA Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herzzentrum Abteilung fur Angiologie', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center Leipzig/Park Hospital', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Kathlisches Klinikum Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'Zentrum fur Diabetes-und GefaBerkrankungen', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Thomas Zeller, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}