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 : March 9, 2023
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
General 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.
- Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
- Subject has a life expectancy of ≤ 12 months.
- Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization.
- Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure.
- 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.
- Subject has major valve disease and underwent intervention within 30 days prior to randomization.
- Subject has received a heart transplant.
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):
- Most recent LVEF ≤25%, or
- Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
- Killip class ≥2 (post STEMI patients)
- Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
- Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
- 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.
- Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit.
- Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
- Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
- Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
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: Krista Stiefelfirstname.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|
|Responsible Party:||Cardiovascular Systems Inc|
|Other Study ID Numbers:||
|First Posted:||April 11, 2017 Key Record Dates|
|Last Update Posted:||March 9, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
minimum stent area
Coronary Artery Disease
Arterial Occlusive Diseases