RecruitingNot ApplicableNCT05489588

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction

Sponsor

W.L.Gore & Associates

Enrollment

165 participants

Start Date

Mar 2, 2023

Study Type

INTERVENTIONAL

Conditions

Venous Ulcer Venous Stenosis Venous Occlusion Venous Leg Ulcer Venous Thromboses Venous Stasis Venous Disease Vein Thrombosis Vein Occlusion Vein Disease

Summary

This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a specialized venous stent (the GORE VIAFORT) in patients who have a blockage in the large veins of the groin and pelvis (iliofemoral veins). This type of blockage can cause severe leg swelling, pain, and skin changes. The stent is inserted through a small puncture to prop open the blocked vein and restore normal blood flow. You may be eligible if: • You are 18 years old or older • You have a non-cancerous blockage in one iliofemoral vein (one leg) • You have moderate to severe symptoms (CEAP class 3 or higher, or significant pain) • You are able to walk and expected to live at least 1 year • Your vein has at least 50% narrowing or complete blockage confirmed by ultrasound or imaging You may NOT be eligible if: • You are pregnant, breastfeeding, or planning to become pregnant within 12 months • You have a recent deep vein thrombosis (DVT) with onset more than 14 days but less than 90 days ago • You have significant blood clotting abnormalities (platelet count below 50,000 or above 1,000,000; INR above 2) • You have severely reduced kidney function (eGFR below 30) or are on dialysis • You have a known history of antiphospholipid syndrome • You have a BMI above 45 • You are actively being treated for cancer Talk to your doctor to see if this trial is right for you.

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

DEVICEGORE® VIAFORT Vascular Stent

Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

Locations(27)

Stanford University School of Medicine

Stanford, California, United States

Advanced Heart and Vein (ClinRe)

Thornton, Colorado, United States

Vascular Care Group

Darien, Connecticut, United States

Yale University

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Manatee Memorial Hospital

Bradenton, Florida, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Vascular Care Group

Wellesley, Massachusetts, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Englewood Hospital & Med Center

Englewood, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Mount Sinai Medical Center

New York, New York, United States

Stony Brook

Stony Brook, New York, United States

St. Peter's Vascular Associates

Troy, New York, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health-Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States

NC Heart and Vascular Research

Raleigh, North Carolina, United States

Bethesda North

Cincinnati, Ohio, United States

University Hospitals Cleveland

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

UT Southwestern

Dallas, Texas, United States

Sentara General Hospital

Norfolk, Virginia, United States

Overlake Hospital

Bellevue, Washington, United States

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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