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
1 other identifier
interventional
2,005
1 country
104
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Mar 2017
Longer than P75 for not_applicable coronary-artery-disease
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2017
CompletedStudy Start
First participant enrolled
March 27, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2025
CompletedOctober 6, 2023
October 1, 2023
7.2 years
February 17, 2017
October 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Acute Minimum Stent Area (MSA)
In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT) at the conclusion of the procedure in the OCT imaging cohort.
Procedure
Target Vessel Failure (TVF)
Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.
1-Year
Secondary Outcomes (2)
Procedural Success
Procedure
Strategy Success
Procedure
Study Arms (2)
Orbital Atherectomy (OA)
ACTIVE COMPARATORThe Diamondback 360® Coronary Orbital Atherectomy System (OAS) will be used for orbital atherectomy (OA) vessel preparation prior to implantation of a drug-eluting stent.
Conventional Balloon Angioplasty
ACTIVE COMPARATORCoronary 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.
Interventions
Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Vessel preparation with conventional and/or specialty balloons
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
University of Alabama - Birmingham
Birmingham, Alabama, 35294, United States
Mercy Gilbert Medical Center
Chandler, Arizona, 85224, United States
St. Luke's Medical Center
Phoenix, Arizona, 85006, United States
Arizona Heart Hospital
Phoenix, Arizona, 85016, United States
Yavapai Regional Medical Center
Prescott, Arizona, 86301, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
University of California - San Diego
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
San Francisco VA Medical Center
San Francisco, California, 942121, United States
Denver VA Medical Center
Denver, Colorado, 80220, United States
Colorado Heart and Vascular
Lakewood, Colorado, 80228, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, 32605, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Heart Institute at Largo
Largo, Florida, 33770, United States
AdventHealth Ocala
Ocala, Florida, 34471, United States
Florida Hospital Orlando
Orlando, Florida, 32806, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, 33410, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
St. Joseph's Hospital
Tampa, Florida, 33614, United States
Atlanta VA Medical Center
Atlanta, Georgia, 30033, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
University of Illinos - Chicago
Chicago, Illinois, 60612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Indiana University
Indianapolis, Indiana, 46202, United States
St. Vincent Heart of Indiana
Indianapolis, Indiana, 46290, United States
Community Hospital
Munster, Indiana, 46321, United States
Reid Health
Richmond, Indiana, 47374, United States
Genesis Medical Center
Davenport, Iowa, 52803, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
U of L Health
Louisville, Kentucky, 40202, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Lafayette General Medical Center
Lafayette, Louisiana, 70503, United States
Ochsner Medical
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04021, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Massachusetts Worcester
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Detroit Medical Center
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433, United States
Essentia Health
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303, United States
Forrest General - Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Stern Cardiovascular
Southaven, Mississippi, 38671, United States
VA St. Louis Healthcare System
St Louis, Missouri, 63106, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
St. Louis University
St Louis, Missouri, 63110, United States
Deborah Heart and Lung Medical Center
Browns Mills, New Jersey, 08015, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morristown Medical Center
Morristown, New Jersey, 07962, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
St. Peter's Hospital
Albany, New York, 12208, United States
New York University School of Medicine
New York, New York, 10016, United States
Columbia University Medical Center / New York-Presbyterian Hospital
New York, New York, 10032, United States
Northwell Health
New York, New York, 10075, United States
Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, 12601, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Montefiore-Einstein Medical Center
The Bronx, New York, 10467, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27109, United States
Mercy Health West Hospital
Cincinnati, Ohio, 45211, United States
University Hospital Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital/Ohio Health
Columbus, Ohio, 43214, United States
Premier Health Specialists
Dayton, Ohio, 45414, United States
Oklahoma Heart Hospital - South Campus
Oklahoma City, Oklahoma, 73119, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
St. John's Health System
Tulsa, Oklahoma, 74104, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Sanford Heart Hospital
Sioux Falls, South Dakota, 57105, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Methodist Health
Dallas, Texas, 75203, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Sentara Cardiovascular
Norfolk, Virginia, 23507, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (3)
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.
PMID: 35288105BACKGROUNDMaehara A, Kirtane AJ, Genereux P, Matsumura M, Lewis BE, Shlofmitz RA, Dohad S, Choudary J, Dahle T, Pineda AM, Shunk KA, Popma A, Redfors B, Ali ZA, Krucoff MW, Armstrong EJ, Kandzari DE, Phalakornkule K, Kraemer C, Stiefel KM, Jones DE, Buccola JR, Chambers JW, Stone GW. Calcium Modification After Orbital Atherectomy and Balloon Angioplasty in Severely Calcified Lesions: The ECLIPSE OCT Substudy. Circ Cardiovasc Interv. 2026 Jan;19(1):e015588. doi: 10.1161/CIRCINTERVENTIONS.125.015588. Epub 2025 Dec 3.
PMID: 41332372DERIVEDKirtane 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.
PMID: 40174596DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajay Kirtane, MD, SM
Columbia University Medical Center / New York-Presbyterian Hospital
- PRINCIPAL INVESTIGATOR
Philippe Généreux, MD
Morristown Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2017
First Posted
April 11, 2017
Study Start
March 27, 2017
Primary Completion
June 12, 2024
Study Completion
June 12, 2025
Last Updated
October 6, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share