The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study

Brief description of study

The purpose of this study is to learn whether the Hancock Jaffe bioprosthetic venous valve(VenoValve®) will help subjects like you with severe chronic venous insufficiency (CVI) in their legs and whether the risks of being treated with the study valve are acceptable. Chronic venous insufficiency (CVI)occurs when the valves inside the veins of your leg do not function properly, causing blood to flow backwards and pool in the lower leg, and leading to elevated venous pressure inside the leg veins. The VenoValve is meant to decrease or eliminate the problems that people have with CVI, such as swelling, discoloration, pain, soreness, itchy or burning sensations, and ulcers (open sores) on the leg.

Clinical Study Identifier: s21-00188
Principal Investigator: Mikel Sadek.

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