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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 Trials | Clareo Health

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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

NCT03108456•Abbott Medical Devices

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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 more criteria

Locations (104)

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

Key Dates

Start Date

March 27, 2017

Primary Completion Date

June 12, 2024

Completion Date

June 12, 2025

Last Updated

October 6, 2023

Enrollment

2,005

ACTUAL participants

Conditions

Coronary Artery DiseaseIschemic Heart DiseaseNon ST Segment Elevation Myocardial Infarction

Interventions

Orbital Atherectomy

DEVICE

Balloon

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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