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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Leg Ulcer; Venous Stasis; Venous Stenosis; Venous Occlusion; Venous Ulcer; Venous Thromboses; Venous Disease; Vein Thrombosis
• Intervention / Treatment: Device: GORE® VIABAHN® FORTEGRA Venous Stent

Detailed Description

A maximum of 35 clinical investigative sites in the U.S. will participate in this study. One hundred and fifty subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent in this study, with a limit of 30 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, and 36 months post-treatment.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carl Conway; Phone Number: 617 595 2277; Email: cconway@wlgore.com
• Study Contact Backup: Name: Chaz Wolf; Phone Number: 928 814 9198; Email: cwolf@wlgore.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GORE® VIABAHN® FORTEGRA Venous Stent	Device: GORE® VIABAHN® FORTEGRA Venous Stent; Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of subjects with primary patency as confirmed by imaging and adverse events	Rate of subjects with freedom from both: stent occlusion due to restenosis or thrombosis as confirmed with imaging, and; clinically driven target lesion revascularization as confirmed with imaging and adverse events	36 months
Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment	Freedom from permanent loss of blood flow through the device, regardless of reintervention	36 months
Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events	Rate of subjects with Repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the study devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of symptoms present at baseline, or the onset of new symptoms related to the target lesion	36 months
Number of subjects with stent embolization as confirmed by adverse events and imaging	Number of subjects with stent embolization	12 months
Number of subjects with device- or index procedure-related death as confirmed with adverse events	Number of subjects with device- or index procedure-related death	30 days
Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events	Number of subjects with clinically significant pulmonary embolism as confirmed via CTA	30 days
Number of subjects with device- or index procedure-related vascular injury as confirmed with adverse events	Number of subjects with device- or index procedure-related vascular injury requiring surgical or endovascular intervention	30 days
Number of subjects with device- or index procedure-related major bleeding events as confirmed with adverse events	Number of subjects with device- or index procedure-related major bleeding events	30 days
5 Level EuroQol-5 Dimension (EQ-5D-5L)	Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 36-month follow-up compared to baseline prior to treatment	36 months
Technical success	Number of subjects with successful delivery and deployment of the stent to the intended location	Index procedure (post-op day 0)
Lesion success	Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or contrast angiography	Index procedure (post-op day 0)

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Erin Murphy, MD, Atrium Health Sanger Heart and Vascular Institute; Principal Investigator: Parag Patel, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Estimated): October 7, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Gore; Venous Disease; Venous Stenosis; Venous Thrombosis; VIAFORT; Vein Stent; Venous occlusion; FORTEGRA; VIABAHN FORTEGRA; Deep Venous Insufficiency; Deep venous; DVT Treatment; Venous Stent; Venous insufficiency treatment options; Venous disease treatment options
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Thrombosis; Skin and Connective Tissue Diseases; Venous Thrombosis; Varicose Ulcer
• Other Study ID Numbers: VNS 25-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No