Primary Results of the GORE® VIABAHN® FORTEGRA Venous Stent Clinical Trial for the Treatment of Symptomatic Inferior Vena Cava Obstruction with or without Combined Iliofemoral Obstruction

Purpose: This trial investigates the safety and effectiveness of the GORE VIABAHN Fortegra Venous Stent for treatment of symptomatic iliocaval obstruction.

Materials and Methods: This is a multicenter, prospective, non-randomized, independently adjudicated clinical trial, previously described {Gibson et al., 2025}. Subjects with symptomatic non-malignant obstruction of the inferior vena cava with or without combined iliofemoral obstruction were eligible for inclusion. Eighty-nine subjects were enrolled at 17 sites across the U.S., Europe, Australia, and New Zealand and treated with the Viabahn Fortegra iliocaval venous stent (WL Gore & Associates, Newark, DE). Median age of subjects was 51 years (min.-max.,18-94) and 34 (38.2%) were female. The primary endpoint is a composite measure of primary patency and freedom from stent embolization at 12 months, and 30-day freedom from pulmonary embolism and device- or procedure-related death, major bleeding, and vascular injury requiring surgical or endovascular intervention. The hypothesis driven secondary endpoint is change in rVCSS pain score from baseline to 12-months.

Results: Of the evaluable subjects, 74.7% (59/79) experienced freedom from a primary endpoint event, exceeding the performance goal of 58% at 12 months (90% CI, 66.6%-82.7%) ( P<0.001). Kaplan-Meier estimates of primary and secondary patency, and freedom from clinically driven target revascularization at 12 months were 83.4% (95% CI, 73.5%-89.8%), 95.1% (95% CI, 87.3%-98.1%), and 89.7% (95% CI, 81.1%-94.5%), respectively. There were no pulmonary embolisms, no device- or procedure-related vascular injuries requiring intervention, four procedure-related major vascular bleeding events, and one procedure-related death through 30 days. There was no stent embolization through 12 months. Of the subjects reporting pain at baseline, 81.0% (51/63) saw an improvement in rVCSS pain score at 12 months with a mean difference of -1.4 ([SD 1.03], P<0.001). Further, the rVCSS index score (-5.5 [SD 4.5], P<0.001) and additional rVCSS domain scores of active ulcer duration (-1.6 [SD 0.85], P=0.027), venous oedema (-1.5 [SD 0.99], P<0.001), and induration (-1.4 [SD 0.69], P<0.001), demonstrated significant improvements in the mean difference between baseline and 12 months.

Conclusion: Endovascular treatment of symptomatic iliocaval obstruction with the purpose-designed venous stent was effective, with high primary patency rates and improved quality of life and demonstrated an acceptable safety profile.