GORE VIABAHN FORTEGRA Venous Stent Post-Approval Study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm study designed to collect real-world performance data on the GORE VIABAHN FORTEGRA Venous Stent. Up to 35 investigative sites in the United States will enroll about 150 subjects, with a maximum of 30 treated per site. Participants will be followed through hospital discharge and at 1, 6, 12, 24, and 36 months to assess outcomes related to venous disease and stent durability. The study focuses on patients requiring venous stenting for conditions such as venous thrombosis, venous stenosis, and venous ulcers, with procedures performed according to the device’s indications for use. Data collection emphasizes safety and real-world effectiveness of the stent beyond initial regulatory approval.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vascular Care Connecticut
  Darien, Connecticut, United States Recruiting
• Medstar Washington Haspital Center
  Washington D.C., District of Columbia, United States Recruiting
• Baylor Research Institute
  Dallas, Texas, United States Recruiting
• UW Medical Center - Northwest Vascular Care
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Erin Murphy, MD — Atrium Health Sanger Heart and Vascular Institute
• Study coordinator: Chaz Wolf
• Email: cwolf@wlgore.com
• Phone: 928 814 9198

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.