🔎 Trials Near Me

Home › Deep Vein Thrombosis › NCT07538609

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

Sponsor: W.L.Gore & Associates · Participants: 150 · Started: Aug 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07538609

Locations in the U.S.

ConnecticutVascular Care Connecticut, Darien
District of ColumbiaMedstar Washington Haspital Center, Washington D.C.
TexasBaylor Research Institute, Dallas
WashingtonUW 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.