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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Coronary Artery Disease, Ischemic Heart Disease, Non ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Orbital Atherectomy
* Device: Balloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orbital Atherectomy (OA)<br>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<br>* Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation<br>|
| Active Comparator: Conventional Balloon Angioplasty<br>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. | Device: Balloon<br>* Vessel preparation with conventional and/or specialty balloons<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Strategy Success | Strategy success, defined as procedural success without crossover to alternative treatment. | Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherectomy, CAD, severe calcium, orbital atherectomy, minimum stent area