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

NCT ID: NCT01961167

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-12-14

Brief Summary

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.

Conditions

Common Iliac Artery Occlusive Disease; External Iliac Artery Occlusive Disease; Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gore VIABAHN BX

Balloon expandable stenting of iliac occlusive disease

Group Type: EXPERIMENTAL

Stenting of common and/or external iliacs

Intervention Type: DEVICE

Balloon expandable stenting of iliac occlusive disease

Interventions

Stenting of common and/or external iliacs

Balloon expandable stenting of iliac occlusive disease

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Holden, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Locations

Auckland City Hospital

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

VBX 13-05

Identifier Type: -

Identifier Source: org_study_id