VIVO Trial Will Evaluate Cook's Zilver Vena Stent to Treat Iliofemoral Venous Obstruction

April 11, 2013—Cook Medical (Bloomington, IN) announced the launch of the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver Vena venous self-expanding stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

According to Cook Medical, the prospective, nonrandomized VIVO study will enroll 243 patients at up to 30 sites in the United States and the Asia-Pacific region. The study will enroll adults 18 years and older who have leg pain that limits usual activities, swelling or skin discoloration in the leg, or a healed or active lower-leg ulcer. There are additional eligibility criteria for the study. The primary study results will be evaluated at 1 year after stent placement, with patient follow-up through 3 years after stent placement. The Zilver Vena venous self-expanding stent is an investigational device that is not approved for sale in the United States, advised Cook Medical.

The study will be led by global principal investigators Anthony J. Comerota, MD, from Jobst Vascular Institute in Toledo, Ohio; and Lawrence “Rusty” Hofmann, MD, from Stanford University.

“This is an important trial, which is intended to objectively assess the endovenous correction of symptomatic iliofemoral vein stenosis with a stent designed for this specific purpose,” commented Dr. Comerota in Cook Medical's press release. “It is a privilege to be a part of this crucial prospective trial.” Dr. Hofmann added, “It is exciting to be a part of the first-ever iliofemoral venous stent trial in the United States. I look forward to the study initiation.”