Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT01961167
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mzambeck@wlgore.com', 'phone': '928-856-4900', 'title': 'Melissa Zambeck', 'organization': 'W. L. Gore & Associates'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Leg ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite of Major Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Percentage of study subjects experiencing a major adverse event (MAE) defined as:\n\n* Device- or procedure-related death within 30 days of the index procedure; and\n* Myocardial Infarction (MI) occurring within 30 days of the index procedure; and\n* Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.', 'unitOfMeasure': 'percentage of subjects experiencing MAE', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes enrolled subjects who either experienced the defined event or were followed for at least 30 days.'}, {'type': 'SECONDARY', 'title': 'Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Discharge', 'description': 'Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed through discharge at day 1 and had relevant procedural data.'}, {'type': 'SECONDARY', 'title': 'Thirty-day Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure.\n\nRutherford categories include:\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.\n\nStage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Primary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 180 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Primary Assisted Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Primary Assisted Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of primary assisted patency at 6 Months. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.', 'unitOfMeasure': 'Lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 180 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Secondary Patency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of secondary patency at 6 months. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 180 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Lesion(s) Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days.'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Lesion(s) Revascularization (TLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 6 months. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 180 days.'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Vessel Revascularization (TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.', 'unitOfMeasure': 'Vessel', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days.'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Vessel Revascularization (TVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 6 months. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.', 'unitOfMeasure': 'percentage of vessel', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 180 days.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Change in Rutherford Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Change in Rutherford Category from pre-procedure at 30 days.\n\nRutherford categories include:\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.\n\nStage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 23 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Rutherford Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Worsended', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Change in Rutherford Category from pre-procedure at 6 months.\n\nRutherford categories include:\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.\n\nStage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Ankle Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'limbs', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '.15', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '0.53'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': 'Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Population includes subjects followed for at least 23 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Ankle Brachial Index (ABI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'limbs', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '.15', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '0.69'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Change in Ankle Brachial Index(ABI) from pre-procedure at 6 months. Larger values indicate a better outcome.The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Freedom From Major Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes number of subjects enrolled into the study who either had defined event or were followed for at least 150 days.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D- Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 23 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D- Mobility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Mobility) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D - Self Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 23 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D - Self Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Self Care) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D - Usual Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. 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EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D - Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D - Pain/Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D - Anxiety/Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D - Anxiety/Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D- Own Health State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Change in Functional Status - EQ5D- Own Health State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Maintained', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Own Health State) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 150 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 day', 'description': 'Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days and had relevant data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 6 Months and had relevant data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device or Procedure-related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From Myocardial Infarction (MI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days', 'description': 'Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 30 days.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Freedom From Major Amputation of the Treated Leg(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects followed for at least 150 days.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gore VIABAHN BX', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'comment': 'Completion of primary endpoint milestone at 30 days and secondary endpoints at 6 months.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Iliac Stenting', 'description': 'Balloon expandable stenting of iliac occlusive disease\n\nStenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '8.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects meeting all eligibility criteria.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2013-10-08', 'resultsFirstSubmitDate': '2017-06-29', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-05', 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Device or Procedure-related Death', 'timeFrame': '30 Days', 'description': 'Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome.'}, {'measure': 'Freedom From Myocardial Infarction (MI)', 'timeFrame': '30 Days', 'description': 'Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome.'}, {'measure': 'Freedom From Major Amputation of the Treated Leg(s)', 'timeFrame': '6 Months', 'description': 'Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component'}], 'primaryOutcomes': [{'measure': 'Composite of Major Adverse Events (MAEs)', 'timeFrame': '30 days', 'description': 'Percentage of study subjects experiencing a major adverse event (MAE) defined as:\n\n* Device- or procedure-related death within 30 days of the index procedure; and\n* Myocardial Infarction (MI) occurring within 30 days of the index procedure; and\n* Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.'}], 'secondaryOutcomes': [{'measure': 'Acute Procedural Success', 'timeFrame': 'Discharge', 'description': 'Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1.'}, {'measure': 'Thirty-day Clinical Success', 'timeFrame': '30 Days', 'description': 'Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure.\n\nRutherford categories include:\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.\n\nStage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene'}, {'measure': 'Primary Patency', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.'}, {'measure': 'Primary Patency', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.'}, {'measure': 'Primary Assisted Patency', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.'}, {'measure': 'Primary Assisted Patency', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of primary assisted patency at 6 Months. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.'}, {'measure': 'Secondary Patency', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.'}, {'measure': 'Secondary Patency', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of secondary patency at 6 months. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.'}, {'measure': 'Freedom From Target Lesion(s) Revascularization (TLR)', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.'}, {'measure': 'Freedom From Target Lesion(s) Revascularization (TLR)', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 6 months. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.'}, {'measure': 'Freedom From Target Vessel Revascularization (TVR)', 'timeFrame': '30 Days', 'description': 'Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.'}, {'measure': 'Freedom From Target Vessel Revascularization (TVR)', 'timeFrame': '6 Months', 'description': 'Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 6 months. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.'}, {'measure': 'Number of Participants With a Change in Rutherford Category', 'timeFrame': '30 Days', 'description': 'Change in Rutherford Category from pre-procedure at 30 days.\n\nRutherford categories include:\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.\n\nStage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene'}, {'measure': 'Number of Participants With Change in Rutherford Category', 'timeFrame': '6 Months', 'description': 'Change in Rutherford Category from pre-procedure at 6 months.\n\nRutherford categories include:\n\nStage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.\n\nStage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene'}, {'measure': 'Change in Ankle Brachial Index (ABI)', 'timeFrame': '30 Days', 'description': 'Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm'}, {'measure': 'Change in Ankle Brachial Index (ABI)', 'timeFrame': '6 Months', 'description': 'Change in Ankle Brachial Index(ABI) from pre-procedure at 6 months. Larger values indicate a better outcome.The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm'}, {'measure': 'Freedom From Major Adverse Events (MAEs)', 'timeFrame': '6 months', 'description': 'Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure.'}, {'measure': 'Change in Functional Status - EQ5D- Mobility', 'timeFrame': '30 days', 'description': 'Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D- Mobility', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Mobility) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Self Care', 'timeFrame': '30 days', 'description': 'Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Self Care', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Self Care) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Usual Activities', 'timeFrame': '30 days', 'description': 'Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Usual Activities', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Usual Activities) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Pain/Discomfort', 'timeFrame': '30 Days', 'description': 'Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Pain/Discomfort', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Anxiety/Depression', 'timeFrame': '30 Days', 'description': 'Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D - Anxiety/Depression', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D- Own Health State', 'timeFrame': '30 Days', 'description': 'Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Change in Functional Status - EQ5D- Own Health State', 'timeFrame': '6 Months', 'description': 'Change in functional status (EQ5D - Own Health State) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.'}, {'measure': 'Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)', 'timeFrame': '30 day', 'description': 'Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.'}, {'measure': 'Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)', 'timeFrame': '6 Months', 'description': 'Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PAD', 'Stent', 'Claudication', 'VIABAHN', 'Gore', 'Endoprosthesis', 'Vascular Diseases', 'Cardiovascular Diseases', 'Iliac Occlusive Disease', 'Balloon Expandable', 'Stent Graft', 'VBX'], 'conditions': ['Common Iliac Artery Occlusive Disease', 'External Iliac Artery Occlusive Disease', 'Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years old;\n* Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;\n* Patient or legal representative is willing to give written informed consent;\n* Patient is capable of complying with protocol requirements, including all follow-up visits;\n* Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).\n* Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery\n\nExclusion Criteria:\n\n* Patient has a life expectancy of less than 1 year;\n* Patient has a known allergy to stent graft components, including stainless steel or heparin;\n* Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;\n* Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation\n* Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment;\n* Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure;\n* Patient is currently participating in this or another investigative clinical study.\n* Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);\n* Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;\n* Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;\n* Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent'}, 'identificationModule': {'nctId': 'NCT01961167', 'briefTitle': 'Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries', 'orgStudyIdInfo': {'id': 'VBX 13-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gore VIABAHN BX', 'description': 'Balloon expandable stenting of iliac occlusive disease', 'interventionNames': ['Device: Stenting of common and/or external iliacs']}], 'interventions': [{'name': 'Stenting of common and/or external iliacs', 'type': 'DEVICE', 'description': 'Balloon expandable stenting of iliac occlusive disease', 'armGroupLabels': ['Gore VIABAHN BX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Andrew Holden, MB ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Auckland City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}