June 25, 2012—Cook Medical (Bloomington, IN) announced the start of the Tibiopedal Access for Crossing Infrainguinal Artery Occlusions study, which will evaluate a retrograde tibiopedal interventional approach in patients with critical limb ischemia.
According to studies cited in the company’s press release, individuals and single centers have reported initial success with the technique that will be evaluated; this approach is often attempted after a traditional antegrade approach fails. Cook stated that this is the first prospective, multicenter study to collect data on the retrograde tibiopedal approach.
Craig Walker, MD, serves as the global Principal Investigator for the study. Dr. Walker is Founder, President, and Medical Director of the Cardiovascular Institute of the South in Louisiana. Twelve sites in the United States and Europe will participate in the study, which will enroll up to 200 patients with totally occluded lower-limb arteries. Physicians will assess the technical success rates of the new procedure both for gaining vascular access via the foot and for crossing the lesion. Patient follow-up will consist of a telephone interview approximately 30 days after the procedure.
Jihad A. Mustapha, MD, Director of Endovascular Intervention at Metro Health Hospital in Wyoming, Michigan, has enrolled and treated the first patients in this study. The initial study results are anticipated to be available in 2013.
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