Abbott is initiating a clinical trial to study the performance of the company's new, investigational Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease.
The results from the SPIRIT PRIME trial will be used to support the regulatory filing for Xience Prime in the U.S. The first patient was enrolled in SPIRIT PRIME at Hillcrest Medical Center in Tulsa, Okla., by Rajesh Chandwaney, MD.
Xience Prime, which uses cobalt chromium technology, is based upon the proven design of the Multi-Link family of stents. The SPIRIT PRIME study is a prospective, multi-center, nonrandomized trial designed to study Xience PRIME in 500 patients at 75 hospital centers, Abbott said.
Patients may receive a maximum of two stents in separate vessels. SPIRIT PRIME will have two arms: the core size arm will follow 400 patients who will be treated with a stent from 2.25 mm to 4 mm in diameter and from 8 mm to 28 mm in length, and the long lesion arm will follow 100 patients who will receive a stent from 2.5 mm to 4 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint is major adverse cardiac events, which is a composite measure of cardiac death, MI and repeat procedure of the target lesion revascularization at one year.
The Abbott Park, Ill.-based company said its Xience Prime utilizes the same drug and biocompatible polymer as Abbott's Xience V everolimus-eluting coronary stent system. However, it offers a new stent design and a modified delivery system designed for greater flexibility and improved deliverability.