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Recruiting Not applicable

The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study

NCT07538609 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2026-08-25
Last updated
2026-10-26

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
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