Principal investigator Morris Mosseri,MD, Chaim Lotan MD, Rifat Jabara MD, Hisham Nassar, MD

Sponsor
Cordis, USA

Monitor
Cordis, Israel

Abstract

This is a multi-center, prospective, randomized, double blind study. It has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx velocityTM stent to the uncoated BX velocityTM stent, both mounted on the RaptorR Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to treatment A or B. Neither the investigator nor the patient will know which stent will be implanted. Patients will be followed at 30 days, 6,9 and 12 months and at 2,3,4, and 5 years pos-procedure, with all patients undergoing repeat angiography at 8 months.
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx velocityTM stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated BX velocityTM balloon-expendable stent, both mounted on the RaptorR Rapid Exchange Stent Delivery System. The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different timepoints (8 months, 1, 3 and 5 years).

Status
Ongoing trial