ECLIPSE: Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug Eluting StEnts
Purpose of the ECLIPSE Trial
Severely calcified coronary lesions represent 6-20%2,3 of the total Percutaneous Coronary Interventions (PCI) market (880K annual procedures). Coronary atherectomy represents < 5% of the PCI market and is not currently classified as the Standard of Care (SOC) in treatment guidelines.
ECLIPSE is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Classic Crown compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions.
- Approximately 2,000 patients with severely calcified coronary lesions will be enrolled at approximately 150 sites in the U.S.
- The imaging cohort will consist of approximately 250 subjects per arm with an optical coherence tomography (OCT) assessment of acute minimum stent area (MSA) at the conclusion of the procedure.
- Co-Primary Endpoints:
- Acute MSA defined as in-stent minimal cross-sectional area as assessed by OCT at the conclusion of the procedure in the OCT imaging cohort.
- 1-year target vessel failure (TVF) defined as the composite of cardiac death, target vessel related myocardial infarction, or ischemia-driven target vessel revascularization.
- Secondary Endpoints:
- Procedural Success defined as successful stent delivery with final Core Lab defined TIMI flow 3 and angiographic in-stent diameter stenosis [DS] ≤ 20%, and with the absence of any of the following: stent loss, coronary perforation, or intra-procedural death.
- Strategy success defined by Procedural Success without crossover to alternative treatment.