Clinicians plan to investigate retrograde tibiopedal interventions, an endovascular technique that may reduce leg amputations in patients with critical limb ischemia (CLI), caused by peripheral arterial disease (PAD). The study, Tibiopedal Access for Crossing Infrainguinal Artery Occlusions, will be led by Craig Walker, MD, founder, president, and medical director of the Cardiovascular Institute of the South, with 13locations throughout south Louisiana. Initial study results are expected in 2013.
With the retrograde tibiopedal approach, a physician gains vascular access at the foot and advances 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. Currently 25 percent of CLI patients undergo amputation as a primary treatment and within two years 25 percent of these patients die and another 30 percent experience additional lower-limb amputation. The mortality rate at five years following amputation can be as high as 68 percent of patients.
The study will take place at 12 different sites in the United States and Europe. Up to 200 totally occluded lower-limb artery patients will be enrolled in order to assess the technical success rate of the new procedure’s ability to enhance vascular access via the foot and for crossing the lesion.
Cook Medical, headquartered in Bloomington, Indiana, will sponsor the study.