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

Sponsor
W.L.Gore & Associates
Study ID
NCT07538609
Status
Not Yet Recruiting

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Conditions

  • Vein Thrombosis
  • Venous Disease
  • Venous Leg Ulcer
  • Venous Occlusion
  • Venous Stasis
  • Venous Stenosis
  • Venous Thromboses
  • Venous Ulcer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GORE® VIABAHN® FORTEGRA Venous Stent — DEVICE
    Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.

Study Details

This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.

Key Dates

First listed
Apr 20, 2026
Start date
Oct 7, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2031

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GORE® VIABAHN® FORTEGRA Venous Stent
    GORE® VIABAHN® FORTEGRA Venous Stent

Primary Outcome Measure

Primary effectiveness as assessed by primary patency [ Time Frame: 12 months ]

Central Contacts

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