The VIVID Trial 12-month outcomes of the Venous stent for the Iliofemoral Vein using the Duo Venous Stent System.

Abstract

Objective: There are varying anatomical and mechanical demands of stent placement in the iliofemoral venous segment; the Duo Venous Stent System is designed to address these issues. The purpose of the VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) study was to investigate the safety and efficacy of the Duo Venous Stent System for the treatment of patients with non-malignant iliofemoral venous obstructive disease.

Methods: This was an international, prospective, multi-center, single-arm study that enrolled patients with symptomatic non-thrombotic (NT), post-thrombotic (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety endpoint was freedom from major adverse events at 30 days post-index procedure. The primary efficacy endpoint was primary patency of stent-bearing segments at 12 months. Secondary and observational endpoints included symptom relief, primary assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months.

Results: A total of 162 patients were enrolled at 30 sites in the United States and Poland. The primary safety endpoint was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P<0.0001). The primary safety endpoint was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy endpoint was met in 90.2% compared with the performance goal of 77.3% (P=0.0002). Primary patency was observed in 95.2% of patients with NT disease, 79.4% of those with PTS, and 86.7% of those with aDVT. No stent fracture, migration, or embolization occurred through 12 months. Patient reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3L, and VEINES-QoL/Sym scores from baseline through 6 and 12 months.

Conclusions: Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of non-malignant iliofemoral venous obstructive disease.