Clinical investigators are for the first time examining the retrograde tibiopedal interventional approach, an endovascular technique that has the potential to reduce the rate of leg amputations by as much as 50% in patients with critical limb ischaemia. Cook Medical is sponsoring the Tibiopedal Access for Crossing Infrainguinal Artery Occlusions study.
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. Individuals(1) and single centres(2) have reported initial success with the technique, which is often tried after a traditional antegrade approach fails. This is the first prospective, multicentre study to collect data on this technique.
“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.”
Currently, 25% of critical limb ischaemia patients undergo amputation as a primary treatment. Within two years of treatment(3), 25% of these patients die and another 30% experience additional lower-limb amputation(3). The mortality rate at five years following amputation can be as high as 68%(4).
Twelve sites in the United States and Europe will participate in the Tibiopedal Access for Crossing Infrainguinal Artery Occlusions study led by global principal investigator, Craig Walker, 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. JA Mustapha, director of endovascular intervention at Metro Health Hospital, has enrolled and treated the first patients.
1 Kavteladze Z, Retrograde recanalization of tibial CTOs. Presented at: TCT 2010; September 21-25, 2010; Washington, DC
2 Montero-Baker M, Schmidt A, Bräunlich S, et al. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther. 2008;15(5):594-604
3 Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33(suppl 1):S1-S75
4 5 Reiber GE, Boyko EJ, Smith DG. Lower extremity foot ulcers and amputations in diabetes. In: Harris MI, Cowie CC, Stern MP, et al., eds. Diabetes in America. 2nd ed. Washington, DC: National Institute of Diabetes and Digestive and Kidney Diseases, 1995:409-428.