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Coronary Artery DiseaseECLIPSENCT03108456

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

A study testing Orbital Atherectomy and Balloon in people with Coronary Artery Disease and Ischemic Heart Disease, run by Abbott Medical Devices at 104 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Orbital Atherectomy and Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,005 participants
Where
104 sitesUnited States
Study dates
27 Mar 2017to 12 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria:

  1. Subject is 18 years of age or older.
  2. Subject presents with:
  3. stable ischemic heart disease or
  4. acute coronary syndrome (NSTEMI or unstable angina), or
  5. stabilized recent STEMI (>48 hours prior to randomization procedure)
  6. 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):
  12. Most recent LVEF ≤25%, or
  13. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
  14. Killip class ≥2 (post STEMI patients)
  15. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
  16. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
  17. 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.
  18. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit.
  19. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
  20. Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
  21. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.

Trial locations and contacts

104 sites in 1 country.

104 sites in 1 country

United States104 sites

  • St. Peter's Hospital

    Albany, New York, 12208

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Atlanta VA Medical Center

    Atlanta, Georgia, 30033

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70809

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Deborah Heart and Lung Medical Center

    Browns Mills, New Jersey, 08015

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Mercy Gilbert Medical Center

    Chandler, Arizona, 85224

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • University of Illinos - Chicago

    Chicago, Illinois, 60612

  • Mercy Health West Hospital

    Cincinnati, Ohio, 45211

  • University Hospital Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital/Ohio Health

    Columbus, Ohio, 43214

  • Metropolitan Cardiology Consultants

    Coon Rapids, Minnesota, 55433

  • Methodist Health

    Dallas, Texas, 75203

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Premier Health Specialists

    Dayton, Ohio, 45414

  • Denver VA Medical Center

    Denver, Colorado, 80220

  • Detroit Medical Center

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Essentia Health

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • The Cardiac & Vascular Institute Research Foundation

    Gainesville, Florida, 32605

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Forrest General - Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Houston Methodist

    Houston, Texas, 77030

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • St. Vincent Heart of Indiana

    Indianapolis, Indiana, 46290

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • University of California - San Diego

    La Jolla, California, 92037

  • Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228

  • Heart Institute at Largo

    Largo, Florida, 33770

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • U of L Health

    Louisville, Kentucky, 40202

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Morristown Medical Center

    Morristown, New Jersey, 07962

  • Community Hospital

    Munster, Indiana, 46321

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Ochsner Medical

    New Orleans, Louisiana, 70121

  • New York University School of Medicine

    New York, New York, 10016

  • Columbia University Medical Center / New York-Presbyterian Hospital

    New York, New York, 10032

  • Northwell Health

    New York, New York, 10075

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Sentara Cardiovascular

    Norfolk, Virginia, 23507

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • AdventHealth Ocala

    Ocala, Florida, 34471

  • Oklahoma Heart Hospital - South Campus

    Oklahoma City, Oklahoma, 73119

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital Orlando

    Orlando, Florida, 32806

  • Palm Beach Gardens Medical Center

    Palm Beach Gardens, Florida, 33410

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • St. Luke's Medical Center

    Phoenix, Arizona, 85006

  • Arizona Heart Hospital

    Phoenix, Arizona, 85016

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Maine Medical Center

    Portland, Maine, 04021

  • Hudson Valley Cardiovascular Practice, PC

    Poughkeepsie, New York, 12601

  • Yavapai Regional Medical Center

    Prescott, Arizona, 86301

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • WakeMed

    Raleigh, North Carolina, 27610

  • Reid Health

    Richmond, Indiana, 47374

  • St. Francis Hospital

    Roslyn, New York, 11576

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • San Francisco VA Medical Center

    San Francisco, California, 942121

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Sanford Heart Hospital

    Sioux Falls, South Dakota, 57105

  • Stern Cardiovascular

    Southaven, Mississippi, 38671

  • VA St. Louis Healthcare System

    St Louis, Missouri, 63106

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • St. Louis University

    St Louis, Missouri, 63110

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • St. Joseph's Hospital

    Tampa, Florida, 33614

  • Montefiore-Einstein Medical Center

    The Bronx, New York, 10467

  • St. John's Health System

    Tulsa, Oklahoma, 74104

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27109

  • University of Massachusetts Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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).

Being tested
Orbital Atherectomy, Balloon
Keywords
atherectomy, CAD, severe calcium, orbital atherectomy, minimum stent area
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orbital AtherectomyDevice

    Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation

  • BalloonDevice

    Vessel preparation with conventional and/or specialty balloons

Study groups in NCT03108456
Study groupRoleWhat they receive
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.
Receives: Device: Orbital Atherectomy
Conventional Balloon AngioplastyActive 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.
Receives: Device: Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Procedure

  2. 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.

    Measured: 1-Year

Secondary outcomes (2)

  1. Procedural Success

    Procedural success, defined as successful stent delivery with final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow three (3) and angiographic in-stent diameter stenosis (DS) ≤20%, and with the absence of any of the following: stent loss, coronary perforation, or intra-procedural death.

    Measured: Procedure

  2. Strategy Success

    Strategy success, defined as procedural success without crossover to alternative treatment.

    Measured: Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study start27 Mar 2017
  3. Primary completion12 Jun 2024 (estimated)
  4. Study completion12 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03108456
Sponsor's protocol ID
CLN-0011-P
Acronym
ECLIPSE
Status last verified
Oct 2023
First submitted
17 Feb 2017
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35288105

  • Maehara 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.

    PubMed 41332372

  • 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.

    PubMed 40174596

Questions about this trial

What is this clinical trial studying?

A study testing Orbital Atherectomy and Balloon in people with Coronary Artery Disease and Ischemic Heart Disease, run by Abbott Medical Devices at 104 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Minimum Stent Area (MSA) (time frame: Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03108456, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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