WAYNE, PA — Vesper Medical, Inc. announced the recent completion of enrollment in its pivotal study – Venous stent for the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous Stent System® (VIVID).
The VIVID Trial enrolled its 160th patient earlier this month. This marks completion of enrollment in the VIVID Trial, well ahead of schedule. VIVID is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of the Vesper DUO Stent System in the treatment of patients with iliofemoral occlusive disease. The Vesper DUO Stent System is designed to be the next generation venous stent technology, uniquely engineered to address the challenges of deep vein obstruction. The modular portfolio is intended to provide physicians clinical versatility with both the DUO-HYBRID™ and DUO-EXTEND™ stent options in a full range of lengths and diameters to customize therapy for each patient depending on their specific disease location within the iliofemoral vein.
“I would like to thank all of the investigators and their teams for the commitment, skill and hard work they brought to the VIVID Trial. This has been a tremendous team effort that will ultimately benefit the millions of patients who suffer today with chronic venous insufficiency,” said Dr. Mahmood Razavi, Director of Clinical Trials at St. Joseph Heart and Vascular Center in Orange, California and principal study investigator.
Chronic venous insufficiency (CVI) is one of the largest burdens on health care systems in both Europe and the United States, affecting up to 35% of the adult population1. CVI can manifest in multiple ways, the most severe forms resulting in skin changes and ulcers, leading to poor quality of life for patients as well as life threatening complications like acute deep vein thrombus formation.2
“The rapid enrollment of the VIVID Trial is a testimonial to the magnitude and severity of chronic venous insufficiency and the dedication of our investigators and employees. We are thrilled to take this important step toward bringing the novel DUO-HYBRID and DUO-EXTEND venous stent technology to patients suffering with CVI,” said Bruce J. Shook, President & CEO of Vesper Medical.
The VIVID Trial is a global study designed to enroll 160 patients at centers in the United States and Europe. It will assess freedom from major adverse events at 30 days post-procedure and primary efficacy of the stented segment at 12 months. Patients enrolled in the study will be followed for 3 years. More information can be found on clinicaltrials.gov/NCT04580160.
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