The prospective, non-randomized, multi-center, single-arm study will have a five-year follow-up and will evaluate the investigational Gore ViaFort vascular stent for the treatment of symptomatic iliofemoral venous obstruction. It will evaluate the device in a treatment range of 10 to 20 mm diameter for iliofemoral veins. The study is being conducted in the U.S. under an approved investigational device exemption.
The first patient was enrolled by David Dexter at Sentara Vascular Specialists in Norfolk, Virginia.
“With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the ViaFort device is compelling to use in a clinical trial,” Dexter said in a news release.
Gore ViaFort uses the company’s expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-wire, sinusoidal-wound nitinol frame. The system holds FDA breakthrough device designation.