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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01961167
Registration number
NCT01961167
Ethics application status
Date submitted
8/10/2013
Date registered
11/10/2013
Date last updated
19/11/2019
Titles & IDs
Public title
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)
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Scientific title
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
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Secondary ID [1]
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VBX 13-05
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Common Iliac Artery Occlusive Disease
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External Iliac Artery Occlusive Disease
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Peripheral Arterial Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Stenting of common and/or external iliacs
Experimental: Gore VIABAHN BX - Balloon expandable stenting of iliac occlusive disease
Treatment: Devices: Stenting of common and/or external iliacs
Balloon expandable stenting of iliac occlusive disease
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of Major Adverse Events (MAEs)
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Assessment method [1]
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Percentage of study subjects experiencing a major adverse event (MAE) defined as:
Device- or procedure-related death within 30 days of the index procedure; and
Myocardial Infarction (MI) occurring within 30 days of the index procedure; and
Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.
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Timepoint [1]
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30 days
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Secondary outcome [1]
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Acute Procedural Success
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Assessment method [1]
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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.
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Timepoint [1]
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Discharge
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Secondary outcome [2]
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Thirty-day Clinical Success
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Assessment method [2]
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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.
Rutherford categories include:
Stage 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.
Stage 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
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Timepoint [2]
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30 Days
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Secondary outcome [3]
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Primary Patency
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Assessment method [3]
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Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
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Timepoint [3]
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30 Days
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Secondary outcome [4]
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Primary Patency
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Assessment method [4]
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Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
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Timepoint [4]
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6 Months
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Secondary outcome [5]
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Primary Assisted Patency
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Assessment method [5]
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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.
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Timepoint [5]
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30 Days
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Secondary outcome [6]
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Primary Assisted Patency
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Assessment method [6]
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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.
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Timepoint [6]
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6 Months
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Secondary outcome [7]
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Secondary Patency
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Assessment method [7]
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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.
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Timepoint [7]
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30 Days
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Secondary outcome [8]
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Secondary Patency
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Assessment method [8]
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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.
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Timepoint [8]
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6 Months
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Secondary outcome [9]
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Freedom From Target Lesion(s) Revascularization (TLR)
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Assessment method [9]
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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.
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Timepoint [9]
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30 Days
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Secondary outcome [10]
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Freedom From Target Lesion(s) Revascularization (TLR)
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Assessment method [10]
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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.
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Timepoint [10]
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6 Months
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Secondary outcome [11]
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Freedom From Target Vessel Revascularization (TVR)
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Assessment method [11]
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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.
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Timepoint [11]
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30 Days
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Secondary outcome [12]
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Freedom From Target Vessel Revascularization (TVR)
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Assessment method [12]
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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.
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Timepoint [12]
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6 Months
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Secondary outcome [13]
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Number of Participants With a Change in Rutherford Category
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Assessment method [13]
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Change in Rutherford Category from pre-procedure at 30 days.
Rutherford categories include:
Stage 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.
Stage 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
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Timepoint [13]
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30 Days
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Secondary outcome [14]
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Number of Participants With Change in Rutherford Category
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Assessment method [14]
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Change in Rutherford Category from pre-procedure at 6 months.
Rutherford categories include:
Stage 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.
Stage 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
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Timepoint [14]
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6 Months
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Secondary outcome [15]
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Change in Ankle Brachial Index (ABI)
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Assessment method [15]
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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
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Timepoint [15]
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30 Days
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Secondary outcome [16]
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Change in Ankle Brachial Index (ABI)
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Assessment method [16]
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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
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Timepoint [16]
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6 Months
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Secondary outcome [17]
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Freedom From Major Adverse Events (MAEs)
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Assessment method [17]
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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.
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Timepoint [17]
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6 months
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Secondary outcome [18]
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Change in Functional Status - EQ5D- Mobility
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Assessment method [18]
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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.
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Timepoint [18]
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30 days
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Secondary outcome [19]
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Change in Functional Status - EQ5D- Mobility
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Assessment method [19]
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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.
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Timepoint [19]
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6 Months
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Secondary outcome [20]
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Change in Functional Status - EQ5D - Self Care
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Assessment method [20]
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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.
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Timepoint [20]
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30 days
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Secondary outcome [21]
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Change in Functional Status - EQ5D - Self Care
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Assessment method [21]
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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.
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Timepoint [21]
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6 Months
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Secondary outcome [22]
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Change in Functional Status - EQ5D - Usual Activities
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Assessment method [22]
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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.
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Timepoint [22]
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30 days
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Secondary outcome [23]
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Change in Functional Status - EQ5D - Usual Activities
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Assessment method [23]
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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.
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Timepoint [23]
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6 Months
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Secondary outcome [24]
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Change in Functional Status - EQ5D - Pain/Discomfort
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Assessment method [24]
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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.
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Timepoint [24]
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30 Days
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Secondary outcome [25]
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Change in Functional Status - EQ5D - Pain/Discomfort
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Assessment method [25]
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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.
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Timepoint [25]
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6 Months
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Secondary outcome [26]
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Change in Functional Status - EQ5D - Anxiety/Depression
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Assessment method [26]
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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.
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Timepoint [26]
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30 Days
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Secondary outcome [27]
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Change in Functional Status - EQ5D - Anxiety/Depression
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Assessment method [27]
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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.
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Timepoint [27]
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6 Months
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Secondary outcome [28]
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Change in Functional Status - EQ5D- Own Health State
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Assessment method [28]
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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.
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Timepoint [28]
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30 Days
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Secondary outcome [29]
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Change in Functional Status - EQ5D- Own Health State
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Assessment method [29]
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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.
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Timepoint [29]
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6 Months
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Secondary outcome [30]
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Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)
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Assessment method [30]
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Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
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Timepoint [30]
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30 day
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Secondary outcome [31]
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Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)
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Assessment method [31]
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Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.
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Timepoint [31]
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6 Months
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Eligibility
Key inclusion criteria
- Patient is at least 18 years old;
- Patient is male, infertile female, or female of childbearing potential practicing an
acceptable method of preventing pregnancy;
- Patient or legal representative is willing to give written informed consent;
- Patient is capable of complying with protocol requirements, including all follow-up
visits;
- Patient has symptomatic claudication or rest pain without tissue loss (Rutherford
Categories 2-4).
- Patient has de novo or restenotic target lesion(s) in the common and/or external iliac
artery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient has a life expectancy of less than 1 year;
- Patient has a known allergy to stent graft components, including stainless steel or
heparin;
- Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic
medications that would prevent compliance with the protocol;
- Patient has a condition (unrelated to the study) that is expected to require
indefinite, or lifelong, anticoagulation
- Patient has had vascular access / catheterization in the lower extremity within 30
days of study enrollment;
- 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;
- Patient is currently participating in this or another investigative clinical study.
- Patient has evidence of angiographically visible thrombus within or adjacent to the
target lesion(s);
- Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would
interfere with the placement of the device;
- Patient has a target lesion requiring atherectomy or any ablative device to facilitate
stent delivery;
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/12/2017
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
W.L.Gore & Associates
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01961167
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andrew Holden, MB ChB
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Address
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Auckland City Hospital
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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0
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Address
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0
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01961167
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