Abbott has initiated enrolling patients for the Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial.
The Excel trial will enroll more than 2,600 patients at up to 165 medical centers in 18 countries including the US, Europe, Asia Pacific, Canada and Latin America.
The global, multi-center, prospective, randomized trial is designed to evaluate the safety and efficacy of the Xience Prime/Xience V Everolimus Eluting Coronary Stent Systems, compared to coronary artery bypass grafting (CABG), or surgery, in select patients with unprotected left main coronary artery disease.
The Excel trial will evaluate unprotected patients with left main disease who have not received grafts to these arteries to determine whether coronary stenting can be an alternative to bypass surgery in these patients.
The primary endpoint of the study is the composite measure of all-cause mortality, myocardial infarction, or stroke at a median follow-up duration of three years, with all randomized patients having reached a minimum of two years’ follow-up.
Abbott Vascular CMO and Medical Affairs divisional vice president Charles Simonton said by leveraging the established safety profile of Xience V and Xience Prime, they will evaluate whether these stents can become a new treatment option for this patient group.