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The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Recruiting
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the study
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
What is being tested
- GORE® VIABAHN® FORTEGRA Venous Stent (device)
Sponsor: W.L.Gore & Associates · Participants: 150 · Started: Aug 25, 2026
Contact the study team
- Chaz Wolf · Phone: 928 814 9198
- Leonard Resecker · Phone: 9287074940
Official record on ClinicalTrials.gov — NCT07538609
Locations in the U.S.
| Connecticut | Vascular Care Connecticut, Darien |
| District of Columbia | Medstar Washington Haspital Center, Washington D.C. |
| Texas | Baylor Research Institute, Dallas |
| Washington | UW Medical Center - Northwest Vascular Care, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.