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)
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|ClinicalTrials.gov Identifier: NCT03108456|
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : June 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Ischemic Heart Disease Non ST Segment Elevation Myocardial Infarction||Device: Orbital Atherectomy Device: Balloon||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 27, 2017|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
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.
Vessel preparation with conventional and/or specialty balloons
- 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.
- 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.
- Procedural Success [ Time Frame: Procedure ]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.
- Strategy Success [ Time Frame: Procedure ]Strategy success, defined as procedural success without crossover to alternative treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108456
|Contact: Amber Dicksonfirstname.lastname@example.org|
|Principal Investigator:||Ajay Kirtane, MD, SM||Columbia University Medical Center / New York-Presbyterian Hospital|
|Principal Investigator:||Philippe Généreux, MD||Morristown Medical Center|