NCT07538609 The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
| NCT ID | NCT07538609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | W.L.Gore & Associates |
| Condition | Venous Thromboses |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-08-25 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-08-25 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
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.
Contact & Investigator
Erin Murphy, MD
PRINCIPAL INVESTIGATOR
Atrium Health Sanger Heart and Vascular Institute
Frequently Asked Questions
Who can join the NCT07538609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Thromboses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07538609 currently recruiting?
Yes, NCT07538609 is actively recruiting participants. Contact the research team at cwolf@wlgore.com for enrollment information.
Where is the NCT07538609 trial being conducted?
This trial is being conducted at Darien, United States, Washington D.C., United States, Dallas, United States, Seattle, United States.
Who is sponsoring the NCT07538609 clinical trial?
NCT07538609 is sponsored by W.L.Gore & Associates. The principal investigator is Erin Murphy, MD at Atrium Health Sanger Heart and Vascular Institute. The trial plans to enroll 150 participants.