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 (ECLIPSE)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    2000
  • sponsor
    Cardiovascular Systems Inc
Updated on 20 October 2022
heart disease
angina pectoris
stemi
unstable angina
acute coronary syndrome
coronary angioplasty

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).

Details
Condition Coronary Artery Disease, Ischemic Heart Disease, Non ST Segment Elevation Myocardial Infarction
Treatment Orbital Atherectomy, Balloon, Balloon
Clinical Study IdentifierNCT03108456
SponsorCardiovascular Systems Inc
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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

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 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
Subject has a life expectancy of ≤ 12 months
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)
Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
Most recent LVEF ≤25%, or
Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated
Killip class ≥2 (post STEMI patients)
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
Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable
Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit
scaffold (BRS), non-stent treatment only
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
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