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%1,2 of the total Percutaneous Coronary Interventions (PCI) market (880K annual procedures). Coronary atherectomy represents < 5%3,4 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.
1. Genereux P, et al. J Am Coll Cardiol. 2014; 63(18): 1845 – 1854.
2. Bourantas CV, et al Heart. 2014; 100(15): 1158-1164.
3. El Hajj M, et al. Cath Lab Digest. 2018;26(6):June 2018.
4. Arora S, et al. Am J Cardiol. 2016;117(4):555-562.
- 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.