A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.

Study Overview
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Brief Summary
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Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.

Detailed Description
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This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the 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(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Stenting of the Common and/or External Iliac Arteries


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; Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate; Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm; Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on). Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses; Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses; Patient has the device advanced across the target lesion(s) and positioned for deployment. 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 an uncorrected bleeding disorder (platelet count < 80,000/µL); Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis; Patient has a known hypercoagulability that cannot be corrected; Patient has evidence of a blood borne infection; 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 index procedure; Patient is currently participating in this or another investigative clinical study. Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s); 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
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 the Common and/or External Iliac Arteries<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, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Success | Number of subjects who experienced 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. | Discharge | 
| 30-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 SAEs within 30 days of the index procedure. | 30 Days | 
| Percentage of Participants With Primary Patency | Kaplan-Meier estimate of primary patency at 30 days. | 30 Days | 
| Percentage of Participants With Primary Patency | Kaplan-Meier estimate of primary patency at 9 months. | 9 Months | 
| Percentage of Participants With Primary Assisted Patency | Kaplan-Meier estimate of primary assisted patency at 30 days. | 30 Days | 
| Percentage of Participants With Primary Assisted Patency | Kaplan-Meier estimate of primary assisted patency at 9 months. | 9 Months | 
| Percentage of Participants With Secondary Patency | Kaplan-Meier estimate of secondary patency at 30 days. | 30 Days | 
| Percentage of Participants With Secondary Patency | Kaplan-Meier estimate of secondary patency at 9 months. | 9 Months | 
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) | Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. | 30 Days | 
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) | Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months. | 9 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) | Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days. | 30 Days | 
| Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) | Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months. | 9 Months | 
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) | Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. | 30 Days | 
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) | Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months. | 9 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) | Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days. | 30 Days | 
| Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) | Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months | 9 Months | 
| Number of Participants With Change in Rutherford Category | Number of participants with change in Rutherford Category from pre-procedure at 30 days. Rutherford Categories: 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 | Number of participants with change in Rutherford Category from pre-procedure at 9 months. Rutherford Categories: 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 | 9 Months | 
| Change in Ankle Brachial Index (ABI) | Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success. | 30 Days | 
| Change in Ankle Brachial Index (ABI) | Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success. | 9 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Mobility | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. | 30 Days | 
| Number of Participants With Change in Functional Status - EQ5D - Mobility | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months. | 9 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Self Care | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. | 30 Days | 
| Number of Participants With Change in Functional Status - EQ5D - Self Care | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months. | 9 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Usual Activities | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. | 30 Days | 
| Number of Participants With Change in Functional Status - EQ5D - Usual Activities | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months. | 9 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. | 30 Days | 
| Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months. | 9 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. | 30 Days | 
| Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months. | 9 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Own Health State | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. | 30 Days | 
| Number of Participants With Change in Functional Status - EQ5D - Own Health State | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months. | 9 Months | 
| Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ) | Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days. | 30 Days | 
| Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ) | Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months. | 9 Months | 
| Percentage of Participants With Primary Patency | Kaplan-Meier estimate of primary patency at 12 months. | 12 Months | 
| Percentage of Participants With Primary Assisted Patency | Kaplan-Meier estimate of primary assisted patency at 12 months. | 12 Months | 
| Percentage of Participants With Secondary Patency | Kaplan-Meier estimate of secondary patency at 12 months. | 12 Months | 
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) | Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months. | 12 Months | 
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) | Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months. | 24 Months | 
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) | Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months. | 36 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) | Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. | 12 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) | Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months. | 24 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) | Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months. | 36 Months | 
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) | Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months. | 12 Months | 
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) | Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months. | 24 Months | 
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) | Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months. | 36 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) | Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months | 12 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) | Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months | 24 Months | 
| Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR) | Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months | 36 Months | 
| Number of Participants With Change in Rutherford Category | Number of participants with change in Rutherford Category from pre-procedure at 12 months. Rutherford Categories: 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 | 12 Months | 
| Number of Participants With Change in Rutherford Category | Number of participants with change in Rutherford Category from pre-procedure at 24 months. Rutherford Categories: 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 | 24 Months | 
| Number of Participants With Change in Rutherford Category | Number of participants with change in Rutherford Category from pre-procedure at 36 months. Rutherford Categories: 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 | 36 Months | 
| Change in Ankle Brachial Index (ABI) | Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success. | 12 Months | 
| Change in Ankle Brachial Index (ABI) | Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success. | 24 Months | 
| Change in Ankle Brachial Index (ABI) | Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success. | 36 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Mobility | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months. | 12 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Mobility | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months. | 24 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Mobility | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months. | 36 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Self Care | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months. | 12 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Self Care | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months. | 24 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Self Care | Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months. | 36 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Usual Activities | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months. | 12 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Usual Activities | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months. | 24 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Usual Activities | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months. | 36 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months. | 12 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months. | 24 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months. | 36 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months. | 12 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months. | 24 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months. | 36 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Own Health State | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months. | 12 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Own Health State | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months. | 24 Months | 
| Number of Participants With Change in Functional Status - EQ5D - Own Health State | Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months. | 36 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