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 investigated the safety and efficacy of the Duo Venous Stent System for the treatment of patients with nonmalignant iliofemoral venous obstructive disease.

Methods: This was an international, prospective, multicenter, single-arm study that enrolled patients with symptomatic nonthrombotic (NT), post-thrombotic syndrome (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety end point was freedom from major adverse events at 30 days after the index procedure. The primary efficacy end point was primary patency of stent-bearing segments at 12 months. Secondary and observational end points 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 end point was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P < .0001). The primary safety end point was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy end point was met in 90.2% compared with the performance goal of 77.3% (P = .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-3 L, 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 nonmalignant iliofemoral venous obstructive disease.

Clinical relevance: The VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) investigational device exemption is the first study of a hybrid, venous stent specifically designed to address the anatomic challenges of the iliofemoral venous system. The Duo Venous Stent System consists of a self-expanding nitinol Hybrid Stent used independently or in conjunction with the flexible extension Duo Extend Stent. This is the first report of primary investigational device exemption VIVID Study, assessing the safety and efficacy of the Duo Venous Stent System to treat patients with nonmalignant, symptomatic iliofemoral venous outflow obstruction. The Duo Venous Stent System successfully met its 12-month safety and effectiveness performance goals.