Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

Recruiting now

Conditions studied: Aortoiliac Occlusive Disease

In brief

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

Key facts

Study ID

NCT06872905

Run by

W.L.Gore & Associates

People needed

158

Starts

2025-05-30

Expected to finish

2027-08-16

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
• Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
• Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
• Age ≥18 years at the time of CERAB procedure.
• Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -

You may not qualify if…

• Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
• Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
• Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.

Where it is running

• Greater Glasgow Health Board — Glasgow, United Kingdom (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• Cooper University Hospital — Camden, New Jersey, United States (enrolling)
• Rutgers — New Brunswick, New Jersey, United States (enrolling)
• Research Foundation SUNY Buffalo — Buffalo, New York, United States (enrolling)
• Mount Sinai Medical Center — New York, New York, United States (enrolling)
• Research Foundation at SUNY Syracuse — Syracuse, New York, United States (enrolling)
• Atrium Health Sanger Heart & Vascular Institute — Charlotte, North Carolina, United States (enrolling)
• Ohio State University Medical Center — Columbus, Ohio, United States (enrolling)
• Geisinger Medical Center — Danville, Pennsylvania, United States (enrolling)
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Sanford Clinical Vascular Associates — Sioux Falls, South Dakota, United States (enrolling)
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• The University of Texas Austin — Austin, Texas, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Carilion Clinic — Roanoke, Virginia, United States (enrolling)
• Marshfield Hospital — Marshfield, Wisconsin, United States (enrolling)
• Marshfield Medical Center - Marshfield — Marshfield, Wisconsin, United States (enrolling)
• University of California — Fresno, California, United States (enrolling)
• Ospedale di Circolo e Fondazione Macchi — Varese, Italy (enrolling)
• Amsterdam UMC Research BV — Amsterdam, Netherlands (enrolling)
• Franciscus — Rotterdam, Netherlands (enrolling)
• Hospital General Universitario de Alicante — Alicante, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.