🏛️ Verified NIH Record • Updated 2026-08-11

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study (NCT05489588)

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

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: W.L.Gore & Associates

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Stanford University School of Medicine — Stanford, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (24 Sites)

  • Stanford University School of Medicine — Stanford, California
  • Vascular Care Group — Darien, Connecticut
  • Yale University — New Haven, Connecticut
  • MedStar Washington Hospital Center — Washington D.C., District of Columbia
  • Manatee Memorial Hospital — Bradenton, Florida
  • Northwestern University — Chicago, Illinois
  • Massachusetts General Hospital — Boston, Massachusetts
  • Vascular Care Group — Wellesley, Massachusetts
  • University of Michigan Hospital — Ann Arbor, Michigan
  • Englewood Hospital & Med Center — Englewood, New Jersey
  • Mount Sinai Medical Center — New York, New York
  • Stony Brook — Stony Brook, New York
  • University of North Carolina - Chapel Hill — Chapel Hill, North Carolina
  • Atrium Health-Sanger Heart and Vascular Institute — Charlotte, North Carolina
  • NC Heart and Vascular Research — Raleigh, North Carolina
  • Bethesda North — Cincinnati, Ohio
  • University Hospitals Cleveland — Cleveland, Ohio
  • Cleveland Clinic Foundation — Cleveland, Ohio
  • University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
  • The Miriam Hospital — Providence, Rhode Island
  • UT Southwestern — Dallas, Texas
  • Sentara General Hospital — Norfolk, Virginia
  • Overlake Hospital — Bellevue, Washington
  • Medical College of Wisconsin - Froedtert Hospital — Milwaukee, Wisconsin

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗