ECLIPSE

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.

References:
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.

Study Design

• 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.

Largest randomized coronary atherectomy trial ever conducted when fully enrolled.

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