News | June 25, 2012

Cook Medical Sponsors First Clinical Study to Examine New Endovascular Technique

Study designed to evaluate retrograde tibiopedal vascular access

June 25, 2012 — 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 percent  in patients with critical limb ischemia (CLI), a manifestation of peripheral arterial disease (PAD)Cook Medical, a company that specializes in interventional medical device technologies, 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 and single centers have reported initial success with the technique, which is often tried after a traditional antegrade approach fails. This is the first prospective, multi-center study to collect data on this technique.

An estimated 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. CLI, which affects up to 300,000 people a year in the United States, is the end stage of lower-extremity PAD and poses a significant risk for limb loss. Currently, 25 percent of CLI patients undergo amputation as a primary treatment. Within two years of treatment, 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.

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, 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. Walker and Mustapha are compensated by Cook Medical for educational lectures they present to physicians on the tibiopedal access procedure.

For more information: www.cookmedical.com

 

 

Related Content

Societies Issue New Performance and Quality Measures for Treating Patients with Heart Attack
News | Cath Lab| October 17, 2017
The American College of Cardiology and the American Heart Association recently released updated clinical performance...
First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial
News | Heart Failure| October 17, 2017
October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S.
Medtronic Launches Concerto 3-D Detachable Coil System
News | Embolization devices| October 16, 2017
October 16, 2017 — Medtronic announced the launch of the Concerto 3-D Detachable Coil System at the Cardiovascular an
Dee Dee Wang runs Henry Ford Hospital's 3D printing lab for its complex structural heart cardiology program.

Dee Dee Wang, M.D., runs Henry Ford Hospital's 3-D printing lab that supports its complex structural heart program.

Feature | 3-D Printing| October 13, 2017 | Dave Fornell
Three-dimensional (3-D) printed anatomic models created from a patient’s computed tomography (CT), magnetic resonance...
Low Mortality and Stroke Risks Displayed for Minimally Invasive Aortic Valve Replacements
News | Heart Valve Technology| October 11, 2017
An analysis of more than 1,000 minimally invasive aortic valve replacements and more than 400 additional associated...
New Evaluation Sends Low-Risk ER Chest Pain Patients Home Sooner
News | Cardiac Diagnostics| October 10, 2017
A new evaluation to determine whether emergency room patients with chest pain can go home and follow up with their...
Videos | Chronic Total Occlusion (CTO)| October 09, 2017
Bill Lombardi, M.D., director of complex coronary artery interventions at the University of Washington, discusses the
BTG Acquires Roxwood Medical
News | Business| October 05, 2017
BTG plc announced it has acquired Roxwood Medical, provider of advanced cardiovascular specialty catheters used in the...
TVA Medical Receives CE Mark for Next-Generation EverlinQ 4 EndoAVF System
News | Vascular Access| October 04, 2017
TVA Medical Inc. announced that its everlinQ 4 endoAVF System has received CE Mark in the European Union. The...
News | Pharmaceuticals| October 04, 2017
October 4, 2017 — MyoKardia Inc.
Overlay Init