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

Abbott Medical Devices104 sites in 1 country2,005 target enrollmentMarch 27, 2017

ConditionsCoronary Artery Disease Ischemic Heart Disease Non ST Segment Elevation Myocardial Infarction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Abbott Medical Devices
Enrollment: 2005
Locations: 104
Primary Endpoint: Target Vessel Failure (TVF)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 27, 2017

End Date

June 12, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•General Exclusion Criteria
•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.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Target Vessel Failure (TVF)

Time Frame: 1-Year

Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.

Acute Minimum Stent Area (MSA)

Time Frame: Procedure

In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT) at the conclusion of the procedure in the OCT imaging cohort.