Twelve-month results from the clinical trial assessing a dedicated venous stent for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction showed the device exceeded its performance goal for freedom from a composite of efficacy and safety events.
The data from 89 patients were presented today at The VEINS 2025 (1–2 November; Las Vegas, USA) by Stephen Black (King’s College London, London, UK).
The prospective, multicentre, non-randomised, single-arm trial of the Viabahn Fortegra (Gore) venous stent—formerly known as Viafort—represents the first such independently adjudicated study examining the use of venous stent placement for the treatment of symptomatic iliocaval venous obstruction, Black told The VEINS 2025.
The overall rate of freedom from composite primary endpoint events was 74.7%, exceeding the 58% performance goal. The composite is made up of freedom from loss of primary patency stent embolisation through 12 months of follow-up; and freedom from device- or procedure-related death, clinically significant pulmonary embolism confirmed via computed tomography angiography (CTA), device- or procedure-related vascular injury requiring surgical or endovascular intervention, and device- or procedure-related major bleeding events through 30 days.
Additionally, there was “a significant improvement in patient pain levels from baseline to 12 months, as seen by a mean reduction in the rVCSS [revised Venous Clinical Severity Score] pain score of less than or equal to 1,” Black revealed.
Some 94.3% of patients in the trial had lesions spanning three-vessel regions—the IVC and bilateral iliofemoral, he said. US enrolment is now complete.
Gore is seeking an indication for use of the device in the IVC under the US Food and Drug Administration (FDA) Breakthrough Device programme. The Viabahn Fortegra is being studied under two investigational device trials, with the other assessing its use for treatment of symptomatic iliofemoral venous obstruction at sites in the USA.
