The GORE VIABAHN FORTEGRA Venous Stent demonstrated strong clinical performance in treating complex deep venous obstruction, achieving an 83.4% primary patency rate at 12 months in the landmark VIAFORT trial, according to results presented at The VEINS 2025 conference in Las Vegas.
Co-Primary Investigator Dr. Stephen Black presented findings from the first prospective study to include the inferior vena cava (IVC), iliac, and femoral veins. The single-arm, non-randomized trial enrolled 89 patients with thrombotic disease across multiple international centers, representing a significant advancement in venous stent research.
Complex Patient Population Shows Strong Outcomes
The trial enrolled patients with acute, subacute, or chronic/post-thrombotic syndrome, with 94.3% of patients presenting lesions spanning three vessel regions. Additionally, 68.5% of patients required stents extending below the inguinal ligament into the common femoral vein, highlighting the complexity of cases treated.
Despite this disease severity, the trial met its primary endpoint with vessel-specific patency rates of 96.5% in the IVC, 88.9% in the left iliofemoral region, and 89.8% in the right iliofemoral region at 12 months.
Exceptional Safety Profile Demonstrated
The trial reported no stent migrations, fractures, vascular injuries, or clinically significant pulmonary embolisms through 12 months of follow-up. No device-related deaths or major bleeding events occurred within 30 days, demonstrating the device's safety profile in this high-risk patient population.
Advancing Venous Intervention Standards
The VIAFORT trial results mark what researchers describe as "a significant milestone in venous stent innovation and patient care." The study's inclusion of multiple vessel regions in a single prospective trial provides unprecedented data for treating complex deep venous obstruction.
The findings were presented as part of the Late-Breaking Clinical Trials session at The VEINS 2025 conference, organized by the VIVA Foundation. The conference brings together international specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery to share advances in venous intervention techniques.
Multiple Venous Studies Showcase Treatment Advances
The VEINS 2025 conference featured several other significant venous intervention studies, including the Spectrum trial comparing cyanoacrylate closure to endothermal ablation for saphenous reflux, and the JURY-2 study examining the impact of junctional reflux on endovenous ablation effectiveness.
These collective findings reinforce the ongoing evolution of venous intervention strategies and the development of evidence-based approaches to treating complex venous disease.
