Enrollment completed for Cook Medical’s study of tibiopedal access technique for treating PAD

Cook Medical has completed patient enrollment in a study evaluating a technique for achieving vascular access via below-the-knee arteries. The new access technique could be used in treating peripheral arterial disease (PAD), including patients with critical limb ischemia (CLI).

“This is a landmark study for Cook Medical and those suffering from CLI”

The Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions study enrolled 200 patients with completely obstructed lower-limb arteries.

The study is led by principal investigator Craig Walker, M.D., president and medical director of the Cardiovascular Institute of the South. Physicians participating in the study are evaluating the tibiopedal access technique, which is used to achieve vascular access via the foot in order to cross blocked arteries in the legs. This technique potentially offers vascular access to patients who otherwise may not have had an interventional treatment option.

Using this approach, a physician accesses the blood vessels below the knee using a needle and advances wire guides and catheters up the leg to reach and cross arterial blockages so that the occlusion can be opened. Individual physicians have reported initial success with the technique, which is often tried after the traditional endovascular approach, usually via the femoral artery, fails.

"This is a landmark study for Cook Medical and those suffering from CLI," said Rob Lyles, vice president and global leader of Cook Medical's Peripheral Intervention division. "We hope that completing enrollment is an important step in bringing the below-the-knee technique to patients, many of whom have had other procedures fail."

The study is being conducted at eight sites across the U.S.: Tucson Medical Center, Tucson, Ariz., Terrebonne Medical Center in Houma, La., First Coast Cardiovascular Institute in Jacksonville, Fla., Metro Heart and General Vascular in Wyoming, Mich., Rex Hospital, Raleigh, N.C., Washington Hospital Center, Washington, D.C., West Virginia University, Charleston Area Medical Center, Charleston, WV, and Mount Sinai Medical Center, Miami Beach, Fla. Patients were also enrolled at Park-Krankenhaus, Leipzig, Germany, Herz-Zentrum, Bad Krozingen, Germany, and Policinico, Abano Terme, Italy in the European Union.