The GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent Post-Approval Study (NCT07538609) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent Post-Approval Study
150 participantsStarted 2026-10-07
Plain-language summary
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent in real-world use.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Preoperative Inclusion Criteria:
* Presence of lesion expected to necessitate treatment with the GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent.
* 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 GOREĀ® VIABAHNĀ® 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 GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent according to the IFU.
What they're measuring
1
Primary effectiveness as assessed by primary patency