Clinical Trials in the USA / NCT07538609
Recruiting
Not applicable
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
NCT07538609 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Venous ThrombosesVenous DiseaseVenous Leg UlcerVenous StasisVenous UlcerVenous StenosisVenous OcclusionVein Thrombosis
Investigational drug(s) / intervention(s)
GORE® VIABAHN® FORTEGRA Venous Stent
GORE® VIABAHN® FORTEGRA Venous Stent: Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
Study 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
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.
Primary outcome measure(s)
- Primary effectiveness as assessed by primary patency — 12 months
Rate of subjects with primary patency as confirmed by imaging and adverse events - Primary safety as assessed by SAEs — 30 days
Rate of subjects with freedom from device- or index procedure-related SAEs
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Vascular Care Connecticut | Darien | Connecticut | Recruiting |
| Medstar Washington Haspital Center | Washington D.C. | District of Columbia | Recruiting |
| Baylor Research Institute | Dallas | Texas | Recruiting |
| UW Medical Center - Northwest Vascular Care | Seattle | Washington | Recruiting |
More W.L.Gore & Associates trials in the USA
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
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Global Registry for Endovascular Aortic Treatment (GREAT)
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Other trials for the same condition
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
Active, not recruiting
Geko™ Cross Therapy Registry - Wound
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Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07538609 on ClinicalTrials.gov ↗ ← All trials in the USA