Abbott has announced the initiation of Spirit Prime, a clinical trial to study the performance of the next-generation Xience Prime Everolimus Eluting Coronary Stent System, for the treatment of coronary artery disease.
Results from Spirit Prime will be used to support the regulatory filing for Xience Prime in the US. The first patient was enrolled into the Spirit Prime clinical trial at Hillcrest Medical Center in Tulsa, Oklahoma.
The Spirit Prime study is a prospective, multi-center, nonrandomized trial designed to study Xience Prime in 500 patients at 75 hospital centers. 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 4.0 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 4.0 mm in diameter and either 33 mm or 38 mm in length.
The primary endpoint is major adverse cardiac events (MACE), which is a composite measure of cardiac death, heart attack (myocardial infarction) and repeat procedure of the treated lesion (target lesion revascularization) at one year.
Charles Simonton, Divisional Vice President of Medical Affairs, and CMO at Abbott, said: Based upon the market-leading technology of Xience V, Xience Prime will be available in a greater breadth of sizes, and is designed to provide improved deliverability. Spirit Prime is expected to build upon the superior outcomes from the SPIRIT family of clinical trials, and the initiation of the study represents Abbott’s commitment to bringing important advances in drug eluting stent technology to clinicians and their patients.