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
- Ischemic Heart DiseaseNon ST Segment Elevation Myocardial InfarctionCoronary Artery Disease
- Interventions
- Device: Orbital AtherectomyDevice: Balloon
- Registration Number
- NCT03108456
- Lead Sponsor
- Abbott Medical Devices
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2005
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Subject is 18 years of age or older.
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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)
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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.
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Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
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Subject is a female who is pregnant.
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Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
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Subject has a life expectancy of ≤ 12 months.
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Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization.
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Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure.
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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.
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Subject has major valve disease and underwent intervention within 30 days prior to randomization.
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Subject has received a heart transplant.
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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)
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Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
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Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
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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.
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Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit.
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Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
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Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
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Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orbital Atherectomy (OA) Orbital Atherectomy 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. Conventional Balloon Angioplasty Balloon 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.
- Primary Outcome Measures
Name Time Method Target Vessel Failure (TVF) 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) 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.
- Secondary Outcome Measures
Name Time Method Procedural Success 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 Procedure Strategy success, defined as procedural success without crossover to alternative treatment.
Trial Locations
- Locations (104)
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Riverside Methodist Hospital/Ohio Health
🇺🇸Columbus, Ohio, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
The Cardiac & Vascular Institute Research Foundation
🇺🇸Gainesville, Florida, United States
AdventHealth Ocala
🇺🇸Ocala, Florida, United States
VA St. Louis Healthcare System
🇺🇸Saint Louis, Missouri, United States
Mercy Gilbert Medical Center
🇺🇸Chandler, Arizona, United States
Baton Rouge General Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Heart Institute at Largo
🇺🇸Largo, Florida, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Yavapai Regional Medical Center
🇺🇸Prescott, Arizona, United States
St. Peter's Hospital
🇺🇸Albany, New York, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Lafayette General Medical Center
🇺🇸Lafayette, Louisiana, United States
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
UF Health Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Massachusetts Worcester
🇺🇸Worcester, Massachusetts, United States
Palm Beach Gardens Medical Center
🇺🇸Palm Beach Gardens, Florida, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Deborah Heart and Lung Medical Center
🇺🇸Browns Mills, New Jersey, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Wellmont CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Montefiore-Einstein Medical Center
🇺🇸Bronx, New York, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Premier Health Specialists
🇺🇸Dayton, Ohio, United States
Northwell Health
🇺🇸New York, New York, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
St. John's Health System
🇺🇸Tulsa, Oklahoma, United States
Sanford Heart Hospital
🇺🇸Sioux Falls, South Dakota, United States
WakeMed
🇺🇸Raleigh, North Carolina, United States
Methodist Health
🇺🇸Dallas, Texas, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
St. Vincent Heart of Indiana
🇺🇸Indianapolis, Indiana, United States
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Mercy Health West Hospital
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of California - San Diego
🇺🇸La Jolla, California, United States
Colorado Heart and Vascular
🇺🇸Lakewood, Colorado, United States
University of Illinos - Chicago
🇺🇸Chicago, Illinois, United States
Stern Cardiovascular
🇺🇸Southaven, Mississippi, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Columbia University Medical Center / New York-Presbyterian Hospital
🇺🇸New York, New York, United States
Hudson Valley Cardiovascular Practice, PC
🇺🇸Poughkeepsie, New York, United States
Houston Methodist
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Atlanta VA Medical Center
🇺🇸Atlanta, Georgia, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Reid Health
🇺🇸Richmond, Indiana, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Durham VA Medical Center
🇺🇸Durham, North Carolina, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University Hospital Cleveland
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Sentara Cardiovascular
🇺🇸Norfolk, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Metropolitan Cardiology Consultants
🇺🇸Coon Rapids, Minnesota, United States
Essentia Health
🇺🇸Duluth, Minnesota, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Ascension St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
St. Luke's Medical Center
🇺🇸Phoenix, Arizona, United States
Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Denver VA Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Oklahoma Heart Hospital - South Campus
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
U of L Health
🇺🇸Louisville, Kentucky, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Forrest General - Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
Ochsner Medical
🇺🇸New Orleans, Louisiana, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States