Cook Medical is sponsoring a study entitled Tibiopedal Access for Crossing Infrainguinal Artery Occlusions.
The company, which describes itself as a global pioneer in interventional medical device technologies, is obviously in the mood for some more pioneering as it endeavours to tap into this new technique involving a retrograde tibiopedal interventional approach to peripheral arteries in patients with critical limb ischemia (CLI).
The approach, if it works, reportedly has the potential to reduce the rate of leg amputations by as much as 50 percent in patients with a manifestation of peripheral arterial disease (PAD).
Studies suggest as many as 27 million people in Europe and North America suffer from PAD, which can lead to CLI, a severe obstruction of the arteries that decreases blood flow to the extremities, producing pain and skin ulcers or sores. The consequences of CLI are frequently multiple amputation and a high subsequent mortality rate (~68%).
With the retrograde tibiopedal approach, which to be honest is new to us, vascular access is achieved as the name suggests in retrograde fashion from the foot, advancing wire guides and catheters up the leg to reach and cross arterial blockages.
Initial success has been reported with the technique, which is often tried after a traditional antegrade approach fails, leading to the initiation of this study which Cook says is the first prospective, multicentre study to collect data.
Twelve sites in the United States and Europe will participate in the study led by global principal investigator, Craig Walker, M.D., founder, president and medical director of the Cardiovascular Institute of the South in Louisiana.
Up to 200 patients with a totally occluded lower-limb artery will be enrolled, and 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. J.A. Mustapha, M.D., director of endovascular intervention at Metro Health Hospital, has enrolled and treated the first patients in this study.
“This endovascular approach developed by leading physicians has the demonstrated potential to address life-limiting and lower-limb-threatening occlusions,” said Rob Lyles, vice president and global leader of Cook’s Peripheral Intervention business unit. “We are committed to enhancing the delivery of quality patient care and look forward to the initial study results in 2013.”
Source: Cook Medical