Prospective Randomized 1:1 Multi-Center Clinical Trial designed to Evaluate Orbital Atherectomy (OA) vessel preparation compared to conventional angioplasty technique for the treatment of severely calcified coronary artery lesions.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Coronary Artery Disease
  • Age: Between 18 - 120 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. 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)
    2. Subjects have signed the Institutional Review Board (IRB) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures.

You may not be eligible for this study if the following are true:

    1. Subjects who have a history of any cognitive or mental health status that would interfere with trial participation.
    2. Subjects participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
    3. Subjects who are pregnant.
    4. Subjects receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
    5. Subjects has a life expectancy of = 12 months.
    6. Subjects has undergone any prior PCI in the target vessel or its branches within 12 months prior to randomization
    7. Subjects has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure
    8. Any cardiac intervention or surgery planned within 12 months post randomization procedure aside from a potential planned staged PCI as part of the randomized treatment strategy
    9. Subjects have major valve disease and underwent intervention within 30 days prior to randomization.
    10. Subjects received a heart transplant.
    11. Evidence of heart failure as per the protocol
    12. Subjects planned use in the randomized lesion(s) of a bare metal stent (BMS),bioresorbable scaffold (BRS), or non-stent treatment only.
    13. Subjects with known sensitivity to contrast media, which cannot be adequately pre- medicated.
    14. Subjects have relative or absolute contraindication to aspirin or all P2Y12 inhibitor agents, or will be unable to take both aspirin and a P2Y12 inhibitor for at least 6 months after PCI
    15. Subjects have history of a stroke or transient ischemic attack (TIA) within six (6) months, or any permanent neurologic deficit.
    16. Subjects have history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
    17. Subjects have evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
    18. Subjects is not an acceptable candidate for emergent coronary artery bypass graft (CABG).
    19. Subjects with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.



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