Recruiting

GORE® VIABAHN® VBX vs. Bare Metal Stenting

Sponsor:

W.L.Gore & Associates

Code:

NCT05811364

Conditions

Aortoiliac Occlusive Disease

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

Study Details

Brief summary:

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Conditions

Aortoiliac Occlusive Disease

Peripheral Arterial Disease

Study ID

NCT05811364

Start date

Oct 17, 2023

Status verified date

May, 2026

Completion date

Jan 31, 2032

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years at time of informed consent signature
  • Informed Consent Form (ICF) is signed by the subject
  • Subject can comply with protocol requirements, including follow-up
  • Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
  • Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)
  • Patient has: Unilateral or bilateral single or multiple lesions (>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length
  • Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm
  • Patient has a sufficient (<50% stenotic) common femoral artery and at least one sufficient (<50% stenotic) femoral artery (deep or superficial).
  • Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off vessel.

Exclusion Criteria:

  • Life expectancy <1 year
  • Patient is pregnant at time of informed consent.
  • Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
  • Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not undergoing hemodialysis.
  • Patient has evidence of a systemic infection.
  • Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
  • Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
  • Patient has previous stenting in the iliac arteries.
  • Patient has previous surgical bypass in the target limb.
  • Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
  • Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.
  • Patient has an abdominal aortic artery lesion or aneurysm.
  • Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
  • Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).
  • Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).

Study Design

Enrollment

244 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: VBX Device Group

Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

active comparator: BMS Control Group

Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease

Interventions

Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.

Primary outcome measure

  • Primary Patency [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Alexander Ambrocik

337-387-4954aambroc@wlgore.com

Enoque Costa

928-525-4044ecosta@wlgore.com

Locations

VA Long Beach Healthcare System

Recruiting

Long Beach, California, United States, 90822

Denver Health and Hospital Authority

Recruiting

Denver, Colorado, United States, 80204

University of Florida - Gainesville

Recruiting

Gainesville, Florida, United States, 32608

Radiology and Imaging Specialists of Lakeland

Recruiting

Lakeland, Florida, United States, 33801

University of South Florida

Recruiting

Tampa, Florida, United States, 33620

Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

Louisiana State University Health Sciences Center

Recruiting

New Orleans, Louisiana, United States, 70112

Beth Israel Deaconess Medical Center, Inc.

Recruiting

Boston, Massachusetts, United States, 02215

Corewell Health System

Recruiting

Grand Rapids, Michigan, United States, 49503

The Curators of the University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Trinity Medical Center

Recruiting

Buffalo, New York, United States, 14214

VA Western New York Healthcare System

Recruiting

Buffalo, New York, United States, 14215

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Mt. Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28210

University Hospitals - Cleveland Medical Center

Recruiting

Ashland, Ohio, United States, 44805

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Portland Health Care System VA

Recruiting

Portland, Oregon, United States, 97239

Providence Heart & Vascular Institute

Recruiting

Wilsonville, Oregon, United States, 97070

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Wellmont Holston Valley Medical Center

Recruiting

Kingsport, Tennessee, United States, 37660

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Sentara Medical Group

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

W.L.Gore & Associates

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by W.L.Gore & Associates on 2026-05-13.