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

W.L. Gore & Associates

Status

Completed

Conditions

External Iliac Artery Occlusive Disease

Common Iliac Artery Occlusive Disease

Peripheral Arterial Disease

Treatments

Device: Stenting of common and/or external iliacs

Study type

Interventional

Funder types

Industry

Identifiers

NCT01961167

VBX 13-05

Details and patient eligibility

About

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.

Enrollment

27 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

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