Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial

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• General Inclusion Criteria:
• Subject is 18 years of age or older.
• Subject presents with:
  • stable ischemic heart disease or
  • acute coronary syndrome (NSTEMI or unstable angina), or
  • stabilized recent STEMI (\>48 hours prior to randomization procedure)
• Subject has signed the Institutional Review Board (IRB) or Ethics Committee (EC) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures.
  • General Exclusion Criteria
• Subject has a history of any cognitive or mental health status that would interfere with trial participation.
• Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
• Subject is a female who is pregnant.
• Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
• Subject has a life expectancy of ≤ 12 months.
• Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization.
• Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure.
• Any cardiac intervention or cardiac surgery planned within 12 months post randomization procedure aside from a potential planned staged PCI as part of the randomized treatment strategy.
• Subject has major valve disease and underwent intervention within 30 days prior to randomization.
• Subject has received a heart transplant.
• Evidence of heart failure by at least one of the following (heart failure assessment is not required per protocol but must be reviewed prior to enrollment if data is available):
  • Most recent LVEF ≤25%, or
  • Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
  • Killip class ≥2 (post STEMI patients)
• Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
• Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
• Subject has a relative or absolute contraindication to dual antiplatelet therapy or (for patients with atrial fibrillation) single antiplatelet therapy (P2Y12 inhibitor preferred) with an anticoagulant for at least 6 months after PCI.
• Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit.
• Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
• Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
• Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.