Study design of the GORE® VIABAHN® FORTEGRA Venous Stent trials for the treatment of symptomatic inferior vena cava obstruction with or without iliofemoral obstruction and unilateral iliofemoral obstruction

<h2>Abstract</h2><h3>Objective</h3> Ambulatory venous hypertension secondary to chronic inferior vena cava (IVC) and iliofemoral obstruction can have considerable impact on patient quality of life including pain, edema, venous ulceration, and exercise intolerance.¹ To date, there are no venous stents available in the United States specifically designed to treat iliocaval obstruction. The GORE® VIAFORT Vascular Stent clinical trials investigate the safety and effectiveness of a novel venous stent developed for the treatment of symptomatic IVC obstruction, with or without iliofemoral obstruction, as well as unilateral symptomatic iliofemoral venous obstruction. <h3>Methods</h3> Two prospective, non-randomized, multicenter, single-armed clinical studies are being conducted at 34 clinical sites. The iliocaval study enrolled 89 patients in the United States, Europe, Australia, and New Zealand, with an additional 23 patients enrolled globally for regulatory purposes, for a total of 112 patients enrolled. Its primary endpoint is a composite measure that includes primary patency and freedom from stent embolization/migration at 12 months, as well as 30-day freedom from clinically significant pulmonary embolism and device- or procedure-related events (e.g. death, major bleeding, or vascular injury requiring surgical or endovascular intervention). The iliofemoral study aims to enroll up to 165 patients in the United States. Its primary composite safety endpoint consists of freedom from stent embolization/migration at 12 months, as well as 30-day freedom from clinically significant pulmonary embolism and device-or procedure- related events (e.g. death, major bleeding, vascular injury requiring surgical or endovascular intervention). The distinct primary efficacy endpoint is primary patency through 12 months. Secondary endpoints for both studies include technical, lesion, and procedural success; primary and secondary patency; clinically driven target lesion revascularization; and device fractures through the 60-month follow-up; stent embolization through 12-month follow-up; individual device- or procedure-related events through 30 days. Quality of life scores assessed through 60 months, include revised Venous Clinical Severity Scale (rVCSS), rVCSS pain score, VEINES, Villalta, and EQ-5D-5L. The primary endpoints and the secondary endpoint of improvement in rVCSS pain score at 12 months, will undergo formal hypothesis testing in both studies. All additional secondary endpoints will be summarized descriptively. <h3>Conclusion</h3> The GORE® VIAFORT Vascular Stent clinical trials are designed to evaluate the safety and efficacy of the unique GORE® VIABAHN® Venous Stent for the treatment of IVC and iliofemoral occlusive disease.