RecruitingNot ApplicableNCT05811364

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Sponsor

W.L.Gore & Associates

Enrollment

244 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Aortoiliac occlusive disease Peripheral Arterial Disease

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent and a medical device called Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for people with aortoiliac occlusive disease and peripheral arterial disease. The study is currently recruiting participants at 43 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStenting 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.

DEVICEStenting 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.

Locations(43)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

VA Long Beach Healthcare System

Long Beach, California, United States

Denver Health and Hospital Authority

Denver, Colorado, United States

North Suburban Medical Center

Denver, Colorado, United States

University of Florida - Gainesville

Gainesville, Florida, United States

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, United States

University of South Florida

Tampa, Florida, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, United States

Corewell Health System

Grand Rapids, Michigan, United States

The Curators of the University of Missouri

Columbia, Missouri, United States

Research Foundation SUNY Buffalo

Amherst, New York, United States

Trinity Medical Center

Buffalo, New York, United States

VA Western New York Healthcare System

Buffalo, New York, United States

New York University School of Medicine

New York, New York, United States

Mt. Sinai Medical Center

New York, New York, United States

Atrium Health

Charlotte, North Carolina, United States

University Hospitals - Cleveland Medical Center

Ashland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Portland Health Care System VA

Portland, Oregon, United States

Providence Heart & Vascular Institute

Wilsonville, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Sentara Medical Group

Norfolk, Virginia, United States

Central Adelaide Local Health Network Incorporated

Adelaide, Australia

Royal Perth Hospital

Nedlands, Australia

Prince of Wales Hospital

Randwick, Australia

Universitats-Herzzentrum Freiburg Bad Krozingen GmbH

Bad Krozingen, Germany

St. Franziskus Hospital

Münster, Germany

Krankenhaus der Barmherzigen Brüder

Regensburg, Germany

Klinikum Stuttgart

Stuttgart, Germany

Ospedale Niguarda Ca'Granda

Milan, MI, Italy

Ospedale Santa Maria della Misericordia

Perugia, Italy

Azienda Complesso Ospedaliero San Filippo Neri

Roma, Italy

Ospedale San Giovanni Molinette

Turin, Italy

Rijnstate Hospital

Arnhem, Netherlands

Stichting Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

Auckland City Hospital

Auckland, New Zealand

East Kent Hospitals University NHS Foundation Trust

Canterbury, United Kingdom

Guy's and St Thomas', NHS Foundation Trust

London, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

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NCT05811364

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