EVALUATION OF TREATMENT STRATEGIES FOR SEVERE CALCIFIC CORONARY ARTERIES: ORBITAL ATHERECTOMY VS. CONVENTIONAL ANGIOPLASTY TECHNIQUE PRIOR TO IMPLANTATION OF DRUGELUTING STENTS: (ECLIPSE)

This is a prospective, post market, randomized one to one (1:1), multicenter trial designed to evaluate coronary artery vessel preparation with an Orbital Atherectomy System (OAS) device compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions. The primary objective is to evaluate OAS compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES). The hypothesis is that OAS will be superior to conventional balloon angioplasty technique by measuring for the 2 co-primary endpoints: 1) Acute Minimum Stent Area (MSA) – In-stent minimal cross-sectional area as assessed at the conclusion of the procedure in the imaging cohort. 2) 1-year Target Vessel Failure - defined as the composite of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization. A secondary endpoint and additional data collection is summarized in the protocol.