Medrad starts patient enrolment in the EURO CANAL study for critical leg ischaemia below the knee

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Medrad Interventional has enrolled the first patient in the EURO CANAL pilot study which is designed to gather early efficacy and safety information with Medrad’s Cotavance paclitaxel coated balloon angioplasty catheter with Paccocath technology compared to standard balloon angioplasty in patients with peripheral artery disease and documented symptomatic critical leg ischaemia. 

EURO CANAL is a prospective randomised study that will include 120 patients at 20 European centres. The endpoints of this pilot are incidence of vessel late lumen loss at six months, amputation-free rates at 12 months and need for revascularisation procedures through 12 months following the angioplasty procedure.

“EURO CANAL will further elucidate the clinical and angiographic utility of the Cotavance balloon catheter in treating atherosclerotic lesions in smaller infrapopliteal arteries,” said Nicolas Diehm, attending physician and director of vascular research, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland, and principal investigator of the study. “Past studies have investigated Cotavance paclitaxel eluting balloon with Paccocath technology compared to standard therapies. EURO CANAL will look at its effects in smaller vessels and more complicated lesions below the knee, an area particularly challenging to treat.”

 

The Cotavance balloon catheter received CE mark approval recently and was announced at the annual congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Munich (10-14 September 2011)

 

The device is not yet approved in the United States. 

 

 

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