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

W.L. Gore & Associates

Status: Begins enrollment in 5 months

Conditions: Venous Leg Ulcer; Venous Ulcer; Vein Thrombosis; Venous Occlusion; Venous Stasis; Venous Disease; Venous Stenosis; Venous Thromboses

Treatments: Device: GORE® VIABAHN® FORTEGRA Venous Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT07538609

VNS 25-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Preoperative Inclusion Criteria:

• 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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

GORE® VIABAHN® FORTEGRA Venous Stent

Experimental group

Description:

GORE® VIABAHN® FORTEGRA Venous Stent

Treatment:

Device: GORE® VIABAHN® FORTEGRA Venous Stent