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

N/ACompletedNCT02080871

W.L.Gore & Associates134 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Peripheral Arterial Disease

Interventions

Stenting of the Common and/or External Iliac ArteriesDEVICE

Balloon expandable stenting of iliac occlusive disease.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is at least 18 years old; 2. Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy; 3. Patient or legal representative is willing to give written informed consent; 4. Patient is capable of complying with protocol requirements, including all follow-up visits; 5. Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4). 6. Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery; 7. Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate; 8. Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm; 9. 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). 10. 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; 11. 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; 12. Patient has the device advanced across the target lesion(s) and positioned for deployment. Exclusion Criteria: 1. Patient has a life expectancy of less than 1 year; 2. Patient has a known allergy to stent graft components, including stainless steel or heparin; 3. Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol; 4. Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation 5. Patient has an uncorrected bleeding disorder (platelet count \< 80,000/µL); 6. Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not on hemodialysis; 7. Patient has a known hypercoagulability that cannot be corrected; 8. Patient has evidence of a blood borne infection; 9. Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment; 10. 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; 11. 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; 12. Patient is currently participating in this or another investigative clinical study. 13. Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s); 14. Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s); 15. Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device; 16. Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery; 17. 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.

Locations (27)

Outcomes

Primary Outcomes

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.

Time frame: 9 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 30 Days

Percentage of Participants With Primary Patency

Kaplan-Meier estimate of primary patency at 30 days.

Time frame: 30 Days

Percentage of Participants With Primary Patency

Kaplan-Meier estimate of primary patency at 9 months.

Time frame: 9 Months

Percentage of Participants With Primary Assisted Patency

Kaplan-Meier estimate of primary assisted patency at 30 days.

Time frame: 30 Days

Percentage of Participants With Primary Assisted Patency

Kaplan-Meier estimate of primary assisted patency at 9 months.

Data from ClinicalTrials.gov

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St. Luke's Medical Center

Phoenix, Arizona, United States

Yale University School of Medicine

New Haven, Connecticut, United States

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Coastal Vascular Institute

Pensacola, Florida, United States

Cardiovascular Associates

Elk Grove Village, Illinois, United States

Iowa Methodist Medical Center

West Des Moines, Iowa, United States

University of Louisville

Louisville, Kentucky, United States

Essentia Institute for Rural Health / St Mary's Hospital

Duluth, Minnesota, United States

...and 17 more locations

Time frame: 9 Months

Percentage of Participants With Secondary Patency

Kaplan-Meier estimate of secondary patency at 30 days.

Time frame: 30 Days

Percentage of Participants With Secondary Patency

Kaplan-Meier estimate of secondary patency at 9 months.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 30 Days

Change in Ankle Brachial Index (ABI)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 9 Months

Percentage of Participants With Primary Patency

Kaplan-Meier estimate of primary patency at 12 months.

Time frame: 12 Months

Percentage of Participants With Primary Assisted Patency

Kaplan-Meier estimate of primary assisted patency at 12 months.

Time frame: 12 Months

Percentage of Participants With Secondary Patency

Kaplan-Meier estimate of secondary patency at 12 months.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 36 Months

Change in Ankle Brachial Index (ABI)

Time frame: 12 Months

Change in Ankle Brachial Index (ABI)

Time frame: 24 Months

Change in Ankle Brachial Index (ABI)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 36 Months