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Abbott Xience V stent trials

This article was originally published in The Gray Sheet

Executive Summary

Company commences enrollment for its 1,125-patient, SPIRIT IV clinical trial to evaluate the everolimus-eluting coronary stent system against Boston Scientific's Taxus Express paclitaxel-eluting stent Aug. 14. The single-blinded, 40-site U.S. study will enroll more complex patients than evaluated in previous studies and include treatment of "up to three de novo...native coronary artery lesions, with a maximum of two lesions per vessel, and in some cases, lesions that are located at areas of bifurcation," Abbott says. Patients will be randomized at a 2:1 ratio for treatment with either Xience V or Taxus. The primary endpoint will be "ischemia-driven target vessel failure at 270 days." Xience V, based on the Multi-Link Vision stent platform, will debut in Europe this year (1"The Gray Sheet" July 24, 2006, p. 9)...

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