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
Coronary Artery DiseaseIschemic Heart DiseaseNon ST Segment Elevation Myocardial Infarction
Investigational drug(s) / intervention(s)
Orbital AtherectomyBalloon
Orbital Atherectomy: Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Balloon: Vessel preparation with conventional and/or specialty balloons
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
General Inclusion Criteria:
1. Subject is 18 years of age or older.
2. Subject presents with:
1. stable ischemic heart disease or
2. acute coronary syndrome (NSTEMI or unstable angina), or
3. stabilized recent STEMI (\>48 hours prior to randomization procedure)
3. 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
1. Subject has a history of any cognitive or mental health status that would interfere with trial participation.
2. Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
3. Subject is a female who is pregnant.
4. Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
5. Subject has a life expectancy of ≤ 12 months.
6. Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization.
7. Subject 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 cardiac surgery planned within 12 months post randomization procedure aside from a potential planned staged PCI as part of the randomized treatment strategy.
9. Subject has major valve disease and underwent intervention within 30 days prior to randomization.
10. Subject has received a heart transplant.
11. 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):
1. Most recent LVEF ≤25%, or
2. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
3. Killip class ≥2 (post STEMI patients)
12. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
13. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
14. 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.
15. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit.
16. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
17. Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
18. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
Primary outcome measure(s)
Acute Minimum Stent Area (MSA) — Procedure In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT) at the conclusion of the procedure in the OCT imaging cohort.
Target Vessel Failure (TVF) — 1-Year Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.
Trial sites (104)
Facility
City
Region
Status
University of Alabama - Birmingham
Birmingham
Alabama
Mercy Gilbert Medical Center
Chandler
Arizona
St. Luke's Medical Center
Phoenix
Arizona
Arizona Heart Hospital
Phoenix
Arizona
Yavapai Regional Medical Center
Prescott
Arizona
Arkansas Heart Hospital
Little Rock
Arkansas
University of California - San Diego
La Jolla
California
Cedars-Sinai Medical Center
Los Angeles
California
Ronald Reagan UCLA Medical Center
Los Angeles
California
San Francisco VA Medical Center
San Francisco
California
Denver VA Medical Center
Denver
Colorado
Colorado Heart and Vascular
Lakewood
Colorado
Yale New Haven Hospital
New Haven
Connecticut
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
The Cardiac & Vascular Institute Research Foundation
Gainesville
Florida
Memorial Regional Hospital
Hollywood
Florida
UF Health Jacksonville
Jacksonville
Florida
Heart Institute at Largo
Largo
Florida
AdventHealth Ocala
Ocala
Florida
Florida Hospital Orlando
Orlando
Florida
Palm Beach Gardens Medical Center
Palm Beach Gardens
Florida
Tallahassee Research Institute
Tallahassee
Florida
St. Joseph's Hospital
Tampa
Florida
Atlanta VA Medical Center
Atlanta
Georgia
Piedmont Atlanta Hospital
Atlanta
Georgia
Northeast Georgia Medical Center
Gainesville
Georgia
University of Illinos - Chicago
Chicago
Illinois
Loyola University Medical Center
Maywood
Illinois
Advocate Christ Medical Center
Oak Lawn
Illinois
Indiana University
Indianapolis
Indiana
St. Vincent Heart of Indiana
Indianapolis
Indiana
Community Hospital
Munster
Indiana
Reid Health
Richmond
Indiana
Genesis Medical Center
Davenport
Iowa
Iowa Heart Center
West Des Moines
Iowa
The University of Kansas Medical Center
Kansas City
Kansas
U of L Health
Louisville
Kentucky
Baton Rouge General Medical Center
Baton Rouge
Louisiana
Cardiovascular Institute of the South
Houma
Louisiana
Lafayette General Medical Center
Lafayette
Louisiana
+ 64 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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