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

W.L. Gore & Associates

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02080871

BES 10-07

Details and patient eligibility

About

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

Full description

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.

Enrollment

134 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.