The study, named SPIRIT IV, will enroll approximately 1,125 patients at around 40 sites in the US. 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. The primary endpoint of the trial is ischemia-driven target vessel failure (TVF) at 270 days.
“SPIRIT IV will allow us to increase our understanding about the potential of Xience V as a next-generation drug eluting stent for physicians caring for the patients with challenging coronary artery disease,” said Dr John Capek, president of cardiac therapies at Abbott Vascular. “We look forward to introducing this therapy in Europe later this year.”
Abbott’s SPIRIT III pivotal study has completed enrollment of 1,002 patients in the randomized US portion of the trial. Enrollment in the 4mm and the Japan arms of the non-randomized portion of its SPIRIT III clinical trial was temporarily suspended earlier this year, but is expected to resume in the near future.