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

NCT07538609 | Not Yet Recruiting FDA Device

• 1 other identifier: VNS 25-06
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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; Venous Stenosis; Venous Occlusion; Vein Thrombosis

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

Outcome Measures

Primary Outcomes (2)

• Primary effectiveness as assessed by primary patency

  Rate of subjects with primary patency as confirmed by imaging and adverse events

  12 months

• Primary safety as assessed by SAEs

  Rate of subjects with freedom from device- or index procedure-related SAEs

  30 days

Secondary Outcomes (11)

• Rate of subjects with primary patency as confirmed by imaging and adverse events

  36 months

• Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment

  36 months

• Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events

  36 months

• Number of subjects with stent embolization as confirmed by adverse events and imaging

  12 months

• Number of subjects with device- or index procedure-related death as confirmed with adverse events

  30 days

Study Arms (1)

GORE® VIABAHN® FORTEGRA Venous Stent

EXPERIMENTAL

GORE® VIABAHN® FORTEGRA Venous Stent

Device: GORE® VIABAHN® FORTEGRA Venous Stent

Interventions

GORE® VIABAHN® FORTEGRA Venous Stent DEVICE

Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.

GORE® VIABAHN® FORTEGRA Venous Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of lesion expected to necessitate treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
• 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.
• 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.

You may not qualify if:

• Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

MeSH Terms

Conditions

Venous Thrombosis; Varicose Ulcer

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Erin Murphy, MD

  Atrium Health Sanger Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

• Parag Patel, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Conway

CONTACT

617 595 2277; cconway@wlgore.com

Chaz Wolf

CONTACT

928 814 9198; cwolf@wlgore.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a prospective, multicenter, single-arm study.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): October 7, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2031
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share