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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Non ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Device: Orbital Atherectomy; Device: Balloon

• Study Type: Interventional
• Enrollment (Actual): 2005
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama - Birmingham
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Mercy Gilbert Medical Center
    • Phoenix, Arizona, United States, 85006
      • St. Luke's Medical Center
    • Phoenix, Arizona, United States, 85016
      • Arizona Heart Hospital
    • Prescott, Arizona, United States, 86301
      • Yavapai Regional Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • La Jolla, California, United States, 92037
      • University of California - San Diego
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • San Francisco, California, United States, 942121
      • San Francisco VA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver VA Medical Center
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32605
      • The Cardiac & Vascular Institute Research Foundation
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Jacksonville, Florida, United States, 32209
      • Uf Health Jacksonville
    • Largo, Florida, United States, 33770
      • Heart Institute at Largo
    • Ocala, Florida, United States, 34471
      • AdventHealth Ocala
    • Orlando, Florida, United States, 32806
      • Florida Hospital Orlando
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Gardens Medical Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
    • Tampa, Florida, United States, 33614
      • St. Joseph's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Atlanta Hospital
    • Atlanta, Georgia, United States, 30033
      • Atlanta VA Medical Center
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinos - Chicago
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart of Indiana
    • Munster, Indiana, United States, 46321
      • Community Hospital
    • Richmond, Indiana, United States, 47374
      • Reid Health
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Medical Center
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • U of L Health
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Baton Rouge General Medical Center
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
    • Lafayette, Louisiana, United States, 70503
      • Lafayette General Medical Center
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical
  • Maine
    • Portland, Maine, United States, 04021
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Worcester
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital and Medical Center
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metropolitan Cardiology Consultants
    • Duluth, Minnesota, United States, 55805
      • Essentia Health
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Forrest General - Hattiesburg Clinic
    • Southaven, Mississippi, United States, 38671
      • Stern Cardiovascular
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University
    • Saint Louis, Missouri, United States, 63106
      • VA St. Louis Healthcare System
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Medical Center
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07962
      • Morristown Medical Center
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Albany, New York, United States, 12208
      • St. Peter's Hospital
    • Bronx, New York, United States, 10467
      • Montefiore-Einstein Medical Center
    • New York, New York, United States, 10016
      • New York University School of Medicine
    • New York, New York, United States, 10075
      • Northwell Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center / New York-Presbyterian Hospital
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Cardiovascular Practice, PC
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
    • Winston-Salem, North Carolina, United States, 27109
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45211
      • Mercy Health West Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospital Cleveland
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital/Ohio Health
    • Dayton, Ohio, United States, 45414
      • Premier Health Specialists
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
    • Oklahoma City, Oklahoma, United States, 73119
      • Oklahoma Heart Hospital - South Campus
    • Tulsa, Oklahoma, United States, 74104
      • St. John's Health System
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Heart Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Dallas, Texas, United States, 75203
      • Methodist Health
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Orbital Atherectomy; Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Active Comparator: 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.	Device: Balloon; Vessel preparation with conventional and/or specialty balloons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Procedure
Strategy Success	Strategy success, defined as procedural success without crossover to alternative treatment.	Procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Cardiovascular Research Foundation, New York
• Investigators: Principal Investigator: Ajay Kirtane, MD, SM, Columbia University Medical Center / New York-Presbyterian Hospital; Principal Investigator: Philippe Généreux, MD, Morristown Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Estimated): June 12, 2024
• Study Completion (Estimated): June 12, 2025

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: atherectomy; CAD; severe calcium; orbital atherectomy; minimum stent area
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: CLN-0011-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes