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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


Brief Summary

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

Primary Purpose
Study Type
Phase III


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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.

Join this Trial

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Study Stats
Protocol No.
Olcay Aksoy
  • UCLA Westwood
For Providers
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