Abbott Vascular enrolls first patient in Xience V drug-eluting stent trial

By Elaine Rigoli

Tampa, Fla., Aug. 14 - Abbott Vascular said Monday that it enrolled the first patient in its Spirit IV clinical trial for the continued evaluation of the safety and efficacy of the Xience V everolimus-eluting coronary stent system for the treatment of coronary artery disease in a more complex patient population, including patients with multi-vessel coronary artery disease requiring multi-vessel stenting.

The Spirit IV study, which will enroll about 1,125 patients at about 40 sites in the United States, is a single-blinded, multi-center clinical trial. The study allows for the treatment of up to three de novo (previously untreated) native coronary artery lesions, with a maximum of two lesions per vessel, and in some cases, lesions that are located at areas of bifurcation, where one vessel branches off to another.

The Xience V stent system will be randomized 2:1 to Boston Scientific's Taxus Express2 Paclitaxel-eluting coronary stent system, according to a news release.

The primary endpoint of the trial is ischemia-driven target vessel failure at 270 days. Patients will be followed out to five years.

Xience V received CE Mark approval earlier this year.

Abbott Vascular, a division of Abbott, is a vascular care business located in Redwood City, Calif.

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