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
NCT ID: NCT03108456
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2005 participants
INTERVENTIONAL
2017-03-27
2025-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orbital Atherectomy (OA)
The Diamondback 360® Coronary Orbital Atherectomy System (OAS) will be used for orbital atherectomy (OA) vessel preparation prior to implantation of a drug-eluting stent.
Orbital Atherectomy
Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Conventional Balloon Angioplasty
Coronary balloons cleared or approved for commercial use by the Food and Drug Administration will be used for conventional balloon angioplasty prior to implantation of a drug-eluting stent.
Balloon
Vessel preparation with conventional and/or specialty balloons
Interventions
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Orbital Atherectomy
Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Balloon
Vessel preparation with conventional and/or specialty balloons
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Cardiovascular Research Foundation, New York
OTHER
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Kirtane, MD, SM
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center / New York-Presbyterian Hospital
Philippe Généreux, MD
Role: PRINCIPAL_INVESTIGATOR
Morristown Medical Center
Locations
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University of Alabama - Birmingham
Birmingham, Alabama, United States
Mercy Gilbert Medical Center
Chandler, Arizona, United States
St. Luke's Medical Center
Phoenix, Arizona, United States
Arizona Heart Hospital
Phoenix, Arizona, United States
Yavapai Regional Medical Center
Prescott, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
University of California - San Diego
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
Denver VA Medical Center
Denver, Colorado, United States
Colorado Heart and Vascular
Lakewood, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Heart Institute at Largo
Largo, Florida, United States
AdventHealth Ocala
Ocala, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Atlanta VA Medical Center
Atlanta, Georgia, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Illinos - Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
St. Vincent Heart of Indiana
Indianapolis, Indiana, United States
Community Hospital
Munster, Indiana, United States
Reid Health
Richmond, Indiana, United States
Genesis Medical Center
Davenport, Iowa, United States
Iowa Heart Center
West Des Moines, Iowa, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
U of L Health
Louisville, Kentucky, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Lafayette General Medical Center
Lafayette, Louisiana, United States
Ochsner Medical
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Massachusetts Worcester
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Detroit Medical Center
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascension St. John Hospital and Medical Center
Detroit, Michigan, United States
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, United States
Essentia Health
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States
Forrest General - Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Stern Cardiovascular
Southaven, Mississippi, United States
VA St. Louis Healthcare System
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Deborah Heart and Lung Medical Center
Browns Mills, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
St. Peter's Hospital
Albany, New York, United States
New York University School of Medicine
New York, New York, United States
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, United States
Northwell Health
New York, New York, United States
Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Montefiore-Einstein Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Durham VA Medical Center
Durham, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Mercy Health West Hospital
Cincinnati, Ohio, United States
University Hospital Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Riverside Methodist Hospital/Ohio Health
Columbus, Ohio, United States
Premier Health Specialists
Dayton, Ohio, United States
Oklahoma Heart Hospital - South Campus
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
St. John's Health System
Tulsa, Oklahoma, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Sanford Heart Hospital
Sioux Falls, South Dakota, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Methodist Health
Dallas, Texas, United States
Dallas VA Medical Center
Dallas, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Sentara Cardiovascular
Norfolk, Virginia, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Genereux P, Kirtane AJ, Kandzari DE, Armstrong EJ, Krucoff MW, Redfors B, Ben-Yehuda O, Lerew DR, Ali ZA, Maehara A, O'Neill WW, Stone GW. Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial. Am Heart J. 2022 Jul;249:1-11. doi: 10.1016/j.ahj.2022.03.003. Epub 2022 Mar 12.
Kirtane AJ, Genereux P, Lewis B, Shlofmitz RA, Dohad S, Choudary J, Dahle T, Pineda AM, Shunk K, Maehara A, Popma A, Redfors B, Ali ZA, Krucoff M, Armstrong E, Kandzari DE, O'Neill W, Kraemer C, Stiefel KM, Jones DE, Chambers J, Stone GW; ECLIPSE Investigators. Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial. Lancet. 2025 Apr 12;405(10486):1240-1251. doi: 10.1016/S0140-6736(25)00450-7. Epub 2025 Mar 30.
Other Identifiers
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CLN-0011-P
Identifier Type: -
Identifier Source: org_study_id
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