Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries

Conditions
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Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease, Peripheral Arterial Disease

Intervention / Treatment
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* Device: Stenting of common and/or external iliacs


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gore VIABAHN BX<br>Balloon expandable stenting of iliac occlusive disease | Device: Stenting of common and/or external iliacs<br>* Balloon expandable stenting of iliac occlusive disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Major Adverse Events (MAEs) | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Success | 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. | Discharge | 
| Thirty-day Clinical Success | 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 | 30 Days | 
| Primary Patency | Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention. | 30 Days | 
| Primary Patency | Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention. | 6 Months | 
| Primary Assisted Patency | 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. | 30 Days | 
| Primary Assisted Patency | 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. | 6 Months | 
| Secondary Patency | 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. | 30 Days | 
| Secondary Patency | 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. | 6 Months | 
| Freedom From Target Lesion(s) Revascularization (TLR) | 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. | 30 Days | 
| Freedom From Target Lesion(s) Revascularization (TLR) | 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. | 6 Months | 
| Freedom From Target Vessel Revascularization (TVR) | 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. | 30 Days | 
| Freedom From Target Vessel Revascularization (TVR) | 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. | 6 Months | 
| Number of Participants With a Change in Rutherford Category | 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 | 30 Days | 
| Number of Participants With Change in Rutherford Category | 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 | 6 Months | 
| Change in Ankle Brachial Index (ABI) | 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 | 30 Days | 
| Change in Ankle Brachial Index (ABI) | 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 | 6 Months | 
| Freedom From Major Adverse Events (MAEs) | 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. | 6 months | 
| Change in Functional Status - EQ5D- Mobility | 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. | 30 days | 
| Change in Functional Status - EQ5D- Mobility | 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. | 6 Months | 
| Change in Functional Status - EQ5D - Self Care | 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. | 30 days | 
| Change in Functional Status - EQ5D - Self Care | 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. | 6 Months | 
| Change in Functional Status - EQ5D - Usual Activities | 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. | 30 days | 
| Change in Functional Status - EQ5D - Usual Activities | 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. | 6 Months | 
| Change in Functional Status - EQ5D - Pain/Discomfort | 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. | 30 Days | 
| Change in Functional Status - EQ5D - Pain/Discomfort | 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. | 6 Months | 
| Change in Functional Status - EQ5D - Anxiety/Depression | 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. | 30 Days | 
| Change in Functional Status - EQ5D - Anxiety/Depression | 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. | 6 Months | 
| Change in Functional Status - EQ5D- Own Health State | 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. | 30 Days | 
| Change in Functional Status - EQ5D- Own Health State | 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. | 6 Months | 
| Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ) | Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days. | 30 day | 
| Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ) | Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, Stent, Claudication, VIABAHN, Gore, Endoprosthesis, Vascular Diseases, Cardiovascular Diseases, Iliac Occlusive Disease, Balloon Expandable, Stent Graft, VBX