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 Disease Clinical Trial

— ECLIPSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03108456
• Other study ID #: CLN-0011-P
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: June 12, 2025

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2005
• Est. completion date: June 12, 2025
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Non ST Segment Elevation Myocardial Infarction

Intervention

Device:
• Orbital Atherectomy
Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
• Balloon
Vessel preparation with conventional and/or specialty balloons

Locations

Country	Name	City	State
United States	St. Peter's Hospital	Albany	New York
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Piedmont Atlanta Hospital	Atlanta	Georgia
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore-Einstein Medical Center	Bronx	New York
United States	Deborah Heart and Lung Medical Center	Browns Mills	New Jersey
United States	Lahey Clinic	Burlington	Massachusetts
United States	Mercy Gilbert Medical Center	Chandler	Arizona
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	University of Illinos - Chicago	Chicago	Illinois
United States	Mercy Health West Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospital Cleveland	Cleveland	Ohio
United States	Riverside Methodist Hospital/Ohio Health	Columbus	Ohio
United States	Metropolitan Cardiology Consultants	Coon Rapids	Minnesota
United States	Dallas VA Medical Center	Dallas	Texas
United States	Methodist Health	Dallas	Texas
United States	Genesis Medical Center	Davenport	Iowa
United States	Premier Health Specialists	Dayton	Ohio
United States	Denver VA Medical Center	Denver	Colorado
United States	Ascension St. John Hospital and Medical Center	Detroit	Michigan
United States	Detroit Medical Center	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Essentia Health	Duluth	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham VA Medical Center	Durham	North Carolina
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	The Cardiac & Vascular Institute Research Foundation	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Forrest General - Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Houston Methodist	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	St. Vincent Heart of Indiana	Indianapolis	Indiana
United States	UF Health Jacksonville	Jacksonville	Florida
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	University of California - San Diego	La Jolla	California
United States	Lafayette General Medical Center	Lafayette	Louisiana
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	Heart Institute at Largo	Largo	Florida
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	U of L Health	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	Methodist University Hospital	Memphis	Tennessee
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Community Hospital	Munster	Indiana
United States	Centennial Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Ochsner Medical	New Orleans	Louisiana
United States	Columbia University Medical Center / New York-Presbyterian Hospital	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Northwell Health	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Cardiovascular	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	AdventHealth Ocala	Ocala	Florida
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Oklahoma Heart Hospital - South Campus	Oklahoma City	Oklahoma
United States	Florida Hospital Orlando	Orlando	Florida
United States	Palm Beach Gardens Medical Center	Palm Beach Gardens	Florida
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Arizona Heart Hospital	Phoenix	Arizona
United States	St. Luke's Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Hudson Valley Cardiovascular Practice, PC	Poughkeepsie	New York
United States	Yavapai Regional Medical Center	Prescott	Arizona
United States	Rhode Island Hospital	Providence	Rhode Island
United States	WakeMed	Raleigh	North Carolina
United States	Reid Health	Richmond	Indiana
United States	St. Francis Hospital	Roslyn	New York
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	St. Louis University	Saint Louis	Missouri
United States	VA St. Louis Healthcare System	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	San Francisco VA Medical Center	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Sanford Heart Hospital	Sioux Falls	South Dakota
United States	Stern Cardiovascular	Southaven	Mississippi
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	St. Joseph's Hospital	Tampa	Florida
United States	St. John's Health System	Tulsa	Oklahoma
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	University of Massachusetts Worcester	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Cardiovascular Research Foundation, New York

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Strategy Success	Strategy success, defined as procedural success without crossover to alternative treatment.	Procedure