Covidien announced commencement of patient enrolment in the DEFINITIVE AR antirestenosis study. This European pilot study is designed to address the challenge of restenosis in patients with peripheral artery disease.
The study will examine the effects of treating a diseased vessel with plaque excision before the use of a drug-coated balloon. Thomas Zeller, Heart Center Bad Krozingen, Germany, and Gunnar Tepe, Academic Hospital of Rosenheim, Germany, are the study’s principal investigators.
The DEFINITIVE AR study will evaluate the use of Covidien’s TurboHawk or SilverHawk plaque excision systems followed by treatment with the Cotavance peripheral paclitaxel-coated angioplasty catheter with Paccocath technology (Medrad Interventional) versus treatment with the Cotavance device alone in patients with peripheral artery disease. The next-generation Cotavance device being used in the study is currently pending regulatory review in Europe and is not approved in the United States, advised Covidien.
“The amount and type of calcified plaque in a patient’s vessel can affect the absorption of antirestenosis drugs,” commented Zeller. “Treating the vessel with plaque excision and removing the calcium prior to the application of the drug-coated balloon may enhance its effect. If this proves to be the case, plaque excision followed by drug-coated balloons may become a key strategy for achieving long-term results when treating long, diffuse, calcified plaque build-up in the leg.”