Recruiting

GORE® VIABAHN® FORTEGRA

Sponsor:

W.L.Gore & Associates

Code:

NCT07538609

Conditions

Venous Thromboses

Venous Disease

Venous Leg Ulcer

Venous Stasis

Venous Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GORE® VIABAHN® FORTEGRA Venous Stent

Study Details

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.

Conditions

Venous Thromboses

Venous Disease

Venous Leg Ulcer

Venous Stasis

Venous Ulcer

Study ID

NCT07538609

Start date

Aug 25, 2026

Status verified date

Oct, 2026

Completion date

May, 2031

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GORE® VIABAHN® FORTEGRA Venous Stent

GORE® VIABAHN® FORTEGRA Venous Stent

Interventions

GORE® VIABAHN® FORTEGRA Venous Stent

Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.

Primary outcome measure

  • Primary effectiveness as assessed by primary patency [ Time Frame: 12 months ]
  • Primary safety as assessed by SAEs [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Chaz Wolf

928 814 9198cwolf@wlgore.com

Leonard Resecker

9287074940lresecke@wlgore.com

Locations

Vascular Care Connecticut

Recruiting

Darien, Connecticut, United States, 06820

Contacts

Gagne, MD

203-548-7860egagne@vascularbreakthroughs.com

Principal Investigator:

Paul Gagne, MD

Medstar Washington Haspital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Abramowitz, MD

202-877-5975kassaye.t.sesaba@medstar.net

Principal Investigator:

Steven Abramowitz, MD

Baylor Research Institute

Recruiting

Dallas, Texas, United States, 75246

Contacts

Foteh, MD

214-821-9600chandrima.nadam@bswhealth.org

Principal Investigator:

Mazin Foteh, MD

UW Medical Center - Northwest Vascular Care

Recruiting

Seattle, Washington, United States, 98133

Contacts

Hemmingway, MD

206-616-6577mihara@uw.edu

Principal Investigator:

Jake Hemmingway, MD

More Information

Sponsor

W.L.Gore & Associates

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • Vein Stent
  • VIAFORT
  • Venous Thrombosis
  • Venous Stenosis
  • Gore
  • Venous occlusion
  • VIABAHN FORTEGRA
  • FORTEGRA
  • Deep Venous Insufficiency
  • Deep venous
  • Venous Disease
  • DVT Treatment
  • Venous Stent
  • Venous insufficiency treatment options
  • Venous disease treatment options

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by W.L.Gore & Associates on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.