Abbott announced enrolment of 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.
Xience V received CE Mark approval earlier this year. The system utilizes the highly deliverable and proven Multi-Link Vision coronary stent platform.
Dr Ali Rizvi, M.D., director of Interventional Cardiology Research at The Heart Centre of Indiana in Indianapolis, enrolled the first patient.
"Preliminary results from clinical studies of the Xience V stent have been promising. SPIRIT IV has been designed to enrol a broader patient group, including patients with multi-vessel coronary artery disease requiring multi-vessel stenting," said Dr. Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, who is principal investigator for Spirit IV. "I look forward to the results of this study of patients that will approximate a real-world population."
The Spirit IV study, which will enrol approximately 1,125 patients at approximately 40 sites in the United States, is a single-blinded, multi-centre 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. The primary endpoint of the trial is ischemia-driven target vessel failure (TVF) at 270 days. Patients will be followed out to five years.
"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 John M. Capek, Ph.D., president, Cardiac Therapies, Abbott Vascular. "We look forward to introducing this therapy in Europe later this year."
Six-month data on the Xience V stent system from the Spirit II trial will be presented at the European Society of Cardiology meeting in Barcelona, Spain, on September 5.
Abbott's Spirit III pivotal study has completed enrolment of 1,002 patients in the randomized US portion of the trial. Enrolment in the 4.0 mm 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.
In April 2006, Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant Corporation. Guidant has been the predominant U.S. market leader in metallic stents since the introduction of the company's first stent system in 1997.
The Spirit First study of the Xience V System, showed positive results at 30 and 180 days for patients with de novo native coronary artery lesions. Spirit II and Spirit III are large-scale pivotal clinical trials comparing Xience V to the Taxus Express2 Paclitaxel Eluting Coronary Stent System.