The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction.

Objective: The objective of this study was to assess the safety and efficacy of a dedicated venous stent (the VICI VENOUS STENT; VENITI, Fremont, Calif) for treatment of symptomatic iliofemoral venous outflow obstruction.

Methods: Thirty patients (24 female; median age, 43 years) were enrolled in the feasibility phase of an international, multicenter investigational device exemption trial from June 2014 to February 2015. All patients exhibited unilateral venous disease with ≥50% stenosis in the iliofemoral veins. Patients within 3 months of acute deep venous thrombosis or with prior surgical or endovascular intervention of the target vessel were excluded. Lesions were primarily of post-thrombotic causes (63%), with a left limb-right limb ratio of 5:1. Nine patients (30%) had lesions extending beneath the inguinal ligament. Median baseline stenosis was 91%; 11 patients (37%) had occlusions.

Results: Fifty-one stents were implanted successfully in 30 patients. Median residual stenosis was 0%, as estimated by venography and intravascular ultrasound. Median follow-up was 701 days. At 12 months, primary, assisted-primary, and secondary patency was 93%, 96%, and 100%, respectively. The stent occluded in two patients through the 12-month window (occurring at 19 and 385 days). Both occlusions occurred in patients presenting with post-thrombotic obstruction. No patients in this cohort exhibited stent fracture at 12 months. Symptomatic improvement of ≥2 points on the Venous Clinical Severity Score was observed in 23 patients (85%) at 12 months (median score improvement, 5 points). There was a median 12-month pain reduction of 20 mm on the visual analog scale score and 15-point improvement on the Chronic Venous Insufficiency Questionnaire score. Scores improved significantly on all three clinical and quality of life scales at 6 and 12 months.

Conclusions: The VICI VENOUS STENT is safe and feasible for treatment of symptomatic iliofemoral venous obstruction, with excellent 12-month patency rates and significant improvement seen in clinical symptoms and quality of life indices. The pivotal phase (170 patients, 22 centers) of this investigational device exemption trial is currently ongoing.