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The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study

W.L.Gore & Associates · NCT07538609

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
150
US sites recruiting
4
Study start
August 25, 2026
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.

Being studied: GORE® VIABAHN® FORTEGRA Venous Stent

Conditions: Venous Thromboses; Venous Disease; Venous Leg Ulcer; Venous Stasis; Venous Ulcer; Venous Stenosis; Venous Occlusion; Vein Thrombosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Preoperative Inclusion Criteria

  • Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator/sub-investigator.
  • Patient is at least 18 years of age.
  • Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
  • Patient is able to provide informed consent themself.

Intraoperative Inclusion Criteria

  • Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
  • Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
  • Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.
  • Patient has adequate inflow/outflow to/from the target lesion(s), per investigator/sub- investigator discretion.
  • Lesion can be traversed with a guidewire.

Intraoperative Exclusion Criteria

  • Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.

Recruiting US locations

  • Vascular Care Connecticut

    Darien, CT 06820

    Site contact: Gagne, MD · 203-548-7860 · egagne@vascularbreakthroughs.com

  • Medstar Washington Haspital Center

    Washington D.C., DC 20010

    Site contact: Abramowitz, MD · 202-877-5975 · kassaye.t.sesaba@medstar.net

  • Baylor Research Institute

    Dallas, TX 75246

    Site contact: Foteh, MD · 214-821-9600 · chandrima.nadam@bswhealth.org

  • UW Medical Center - Northwest Vascular Care

    Seattle, WA 98133

    Site contact: Hemmingway, MD · 206-616-6577 · mihara@uw.edu

Study contacts (from the official record)

  • Chaz Wolf · 928 814 9198 · cwolf@wlgore.com
  • Leonard Resecker · 9287074940 · lresecke@wlgore.com
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study (NCT07538609) | Bored Studies