Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00739102
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2008-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pschleck@its.jnj.com', 'phone': '908-541-4564', 'title': 'Patricia Schleckser, Director Medical Affairs', 'organization': 'Cordis Corporation, a Johnson & Johnson company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.', 'otherNumAtRisk': 250, 'otherNumAffected': 93, 'seriousNumAtRisk': 250, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Catheter site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'In-stent arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 56, 'numAffected': 48}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Femoral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '12-month Primary Patency Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'title': 'Subjects Achieved Primary Patency', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000', 'lowerLimit': '60'}]}]}, {'title': "Subjects Didn't Achieve Primary Patency", 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.437', 'groupIds': ['OG000'], 'paramType': 'Proportion - 12-month patency rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.665', 'ciLowerLimit': '0.6', 'ciUpperLimit': '0.725', 'pValueComment': 'The observed rate of primary patency at 12 month was 66.5% (143/215) with a lower 95% confidence interval of 60.0%.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.032', 'estimateComment': 'The 95% confidence intervals and the standard error were calculated using the Agresti-Coull method', 'groupDescription': 'The null hypothesis to be tested was Ho: P = 0.66 against Ha: P \\> 0.66, where 0.66 was the Objective Performance Criteria (OPC). A sample size of 212 subjects was required to achieve 90% power to reject the 66% 12-months patency rate at a one-sided 2.5% significance level when the unknown true patency is at 76%.', 'statisticalMethod': 'Agresti-Coull method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \\>50% with a peak systolic velocity ratio \\>2.0 as measured by Duplex ultrasound.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As a subset of the modified ITT, this analysis population consisted of the subjects who had ultrasound assessment at 12 months or had target vessel revascularization (TVR) performed by 12 months.'}, {'type': 'SECONDARY', 'title': 'Death Rate at 30-day Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 30-day post procedure'}, {'type': 'SECONDARY', 'title': 'Death at 12-month Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Death Rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '4.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 12-month post procedure'}, {'type': 'SECONDARY', 'title': 'Index Limb Amputation at 30-day Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Index Limb Amputation Rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 day', 'description': 'Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 30 days post procedure'}, {'type': 'SECONDARY', 'title': 'Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinically Driven TVR Rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and \\>50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of \\>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 30-day post procedure'}, {'type': 'SECONDARY', 'title': 'Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinically Driven TVR Rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '9.5', 'ciUpperLimit': '18.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and \\>50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of \\>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 12-month post procedure'}, {'type': 'SECONDARY', 'title': 'Stent Fracture at 12-month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Stent Fracture Rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '4.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Stent fracture was assessed by x-ray evaluation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 12-month post procedure'}, {'type': 'SECONDARY', 'title': 'Index Limb Ischemia at 6-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Index Limb Ischemia Rate (%)', 'ciPctValue': '95', 'paramValue': '5.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 6-month post procedure'}, {'type': 'PRIMARY', 'title': 'Primary Safety Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'title': 'Subjects Achieved Primary Safety Endpoint', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}]}]}, {'title': "Subjects Didn't Achieve Primary Safety Endpoint", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Primary safety endpoint rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '98.2', 'ciUpperLimit': '100', 'groupDescription': 'The null hypothesis to be tested was Ho: P = 0.88 against Ha: P \\> 0.88, where 0.88 was the Objective Performance Criteria (OPC).', 'statisticalMethod': 'Agresti-Coull method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and \\>50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of \\>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 30 days post procedure'}, {'type': 'SECONDARY', 'title': 'Index Limb Ischemia at 12-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Index Limb Ischemia Rate (%)', 'ciPctValue': '95', 'paramValue': '8.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 12-month post procedure'}, {'type': 'SECONDARY', 'title': 'Rutherford/Becker Classification at 30-day Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'title': 'Rutherford/Becker Classification - 0', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 1', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 2', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:\n\n1. Stage 0 - Asymptomatic, no hemodynamically significant occlusive disease\n2. Stage 1 - Mild claudication\n3. Stage 2 - Moderate claudication\n4. Stage 3 - Severe claudication\n5. Stage 4 - Ischemic rest pain\n6. Stage 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia\n7. Stage 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 30-day post procedure'}, {'type': 'SECONDARY', 'title': 'Rutherford / Becker Classification Category at 12-month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'title': 'Rutherford/Becker Classification - 0', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 1', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 2', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 3', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Rutherford/Becker Classification - 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 12-month post procedure'}, {'type': 'SECONDARY', 'title': 'Major Adverse Events at 12-month Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Major adverse event rate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.4', 'ciLowerLimit': '10.2', 'ciUpperLimit': '19.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Active subjects in the Modified ITT population at 12-month post procedure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'S.M.A.R.T.® Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T. ®Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 12-Month Follow-up', 'groupId': 'FG000', 'numSubjects': '235'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'A total of 250 patients were enrolled from August 14, 2008 to March 15, 2010 across 39 clinical sites in the U.S.', 'preAssignmentDetails': 'This is a multi-center, non-randomized, single-arm, prospective trial. Patients were eligible for enrollment if they met all inclusion criteria and none of the exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'S.M.A.R.T.™ Nitinol Stent System', 'description': 'The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.71', 'spread': '10.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '154', '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': '240', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}]}]}, {'title': 'Middle Eastern', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '250', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Modified Intent-To-Treat (ITT) Population'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2009-11-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-28', 'studyFirstSubmitDate': '2008-08-20', 'dispFirstSubmitQcDate': '2009-11-11', 'resultsFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2008-08-20', 'dispFirstPostDateStruct': {'date': '2009-11-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-17', 'studyFirstPostDateStruct': {'date': '2008-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12-month Primary Patency Rate', 'timeFrame': '12 months', 'description': 'Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \\>50% with a peak systolic velocity ratio \\>2.0 as measured by Duplex ultrasound.'}, {'measure': 'Primary Safety Endpoint', 'timeFrame': '30 days', 'description': 'Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and \\>50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of \\>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.'}], 'secondaryOutcomes': [{'measure': 'Death Rate at 30-day Post Procedure', 'timeFrame': '30 days'}, {'measure': 'Death at 12-month Post Procedure', 'timeFrame': '12 months'}, {'measure': 'Index Limb Amputation at 30-day Follow up', 'timeFrame': '30 day', 'description': 'Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.'}, {'measure': 'Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure', 'timeFrame': '30 days', 'description': 'A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and \\>50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of \\>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.'}, {'measure': 'Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure', 'timeFrame': '12 months', 'description': 'A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and \\>50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of \\>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.'}, {'measure': 'Stent Fracture at 12-month Follow Up', 'timeFrame': '12 months', 'description': 'Stent fracture was assessed by x-ray evaluation.'}, {'measure': 'Index Limb Ischemia at 6-month Follow up', 'timeFrame': '6 months', 'description': 'Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.'}, {'measure': 'Index Limb Ischemia at 12-month Follow up', 'timeFrame': '12 months', 'description': 'Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.'}, {'measure': 'Rutherford/Becker Classification at 30-day Follow Up', 'timeFrame': '30 days', 'description': 'The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:\n\n1. Stage 0 - Asymptomatic, no hemodynamically significant occlusive disease\n2. Stage 1 - Mild claudication\n3. Stage 2 - Moderate claudication\n4. Stage 3 - Severe claudication\n5. Stage 4 - Ischemic rest pain\n6. Stage 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia\n7. Stage 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable'}, {'measure': 'Rutherford / Becker Classification Category at 12-month Follow Up', 'timeFrame': '12 months'}, {'measure': 'Major Adverse Events at 12-month Post Procedure', 'timeFrame': '12 months', 'description': 'Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Superficial Femoral Artery', 'Nitinol Self-Expandable Stent System'], 'conditions': ['Superficial Femoral Artery Disease']}, 'descriptionModule': {'briefSummary': 'A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250 patients with obstructive superficial femoral artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>/= 30 years\n* For women of child bearing potential, a pregnancy test within 7 days prior to index procedure (the test results must be negative to be eligible).\n* Symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4) with a resting or exercise ABI \\</= 0.8.\n* A single superficial femoral artery lesion with \\> 50% stenosis or total occlusion.\n* Stenotic lesion or occluded length within the same vessel (one long or multiple serial lesions) \\>/= 4.0 cm to \\</= 15.0 cm, by visual estimate. The stenosis must be treatable with no more than two stents, minimizing the stent overlap whose combined length \\</= 170 mm.\n* Reference vessel diameter (RVD) \\>/= 4.0 mm and \\</= 6.0 mm by visual assessment.\n* All lesions are to be located at least three centimeters proximal to the superior edge of the patella.\n* Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\\< 50% stenosis) to the ankle or foot.\n* The guidewire is across the target lesion(s) and located intraluminally within the distal vessel.\n* Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \\> 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as \\<30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, if the peak to peak pressure gradient across the inflow lesion is \\</= 20mmHg and the peak to peak pressure gradient across the SFA target lesion is \\>/= 20mmHg, then the patient will be included in the study.\n* A patient with bilateral obstructive SFA disease is eligible for enrollment into the study.\n* Eligibility for standard surgical repair, if necessary.\n* A patient who requires a coronary intervention, should have it performed at least 7 days prior to the treatment of the target lesion.\n* Patient or authorized representative must provide written informed consent and written HIPAA authorization prior to initiation of study procedures.\n* Patient must be willing to comply with the specified follow-up evaluation schedule.\n\nExclusion Criteria:\n\n* Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days.\n* Receiving dialysis or immunosuppressant therapy.\n* Thrombolysis of the target vessel within 72 hours prior to the index procedure where complete resolution of the thrombus was not achieved.\n* Recent stroke within past 90 days.\n* Femoral, iliac or aortic aneurysm or aneurysm in the SFA or popliteal artery within past 5 years.\n* Required stent placement via a popliteal approach.\n* Required stent placement across or within 0.5 cm of the SFA / PFA bifurcation.\n* Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as severe calcification which is resistant to stenting, or for in-stent restenosis.\n* Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.\n* Previously deployed stent within the SFA of the target limb.\n* Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.\n* Presence of thrombus prior to crossing the lesion\n* Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)\n* Serum creatinine level \\>/= 2.5 mg/dl at time of screening visit\n* Known or suspected active infection at the time of the procedure\n* Bleeding diathesis\n* Presence of an aortic, iliac or femoral artificial graft\n* Life expectancy less than one year, or any other factors preventing clinical followup.\n* Use of cryoplasty, laser, or atherectomy devices on the target vessel at the time of index procedure\n* In-stent restenotic lesions at time of procedures.\n* Restenotic lesion that had previously been treated by atherectomy, laser, or cryoplasty within 90 days of the index procedure.\n* Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.\n* Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.\n* Patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.\n* Patient has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study. Interventional procedures performed to the ipsilateral iliac artery to provide access will be allowed.'}, 'identificationModule': {'nctId': 'NCT00739102', 'acronym': 'STROLL', 'briefTitle': 'S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL)', 'orgStudyIdInfo': {'id': 'P05-6201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'S.M.A.R.T.® Nitinol Self-Expandable Stent System', 'interventionNames': ['Device: S.M.A.R.T. ® Stent']}], 'interventions': [{'name': 'S.M.A.R.T. ® Stent', 'type': 'DEVICE', 'description': 'The Cordis S.M.A.R.T.® Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'William Gray, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}