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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 (ECLIPSE)

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ClinicalTrials.gov Identifier: NCT03108456
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 26, 2021
Sponsor:
Collaborator:
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
Cardiovascular Systems Inc

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date April 26, 2021
Actual Study Start Date  ICMJE March 27, 2017
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • Minimum Stent Area (MSA) [ Time Frame: Procedure ]
    In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT).
  • 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 clinically driven target vessel revascularization.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • 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, cross-over to alternative strategy, coronary perforation, or intra-procedural death
  • Strategy Success [ Time Frame: Procedure ]
    Strategy success, defined as procedural success without crossover or stent loss
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Ischemic Heart Disease
  • Non ST Segment Elevation Myocardial Infarction
Intervention  ICMJE
  • Device: Orbital Atherectomy
    Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
  • Device: Balloon
    Vessel preparation with conventional and/or specialty balloons
Study Arms  ICMJE
  • 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.
    Intervention: Device: Orbital Atherectomy
  • 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.
    Intervention: Device: Balloon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2024
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

General Inclusion Criteria:

  1. Subject is 18 years of age or older.
  2. Subject presents with:

    1. stable ischemic heart disease or
    2. acute coronary syndrome (NSTEMI or unstable angina), or
    3. stabilized recent STEMI (>48 hours prior to randomization procedure)
  3. 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

  1. Subject has a history of any cognitive or mental health status that would interfere with trial participation.
  2. Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint.
  3. Subject is a female who is pregnant.
  4. Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure.
  5. Subject has a life expectancy of ≤ 12 months.
  6. Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization.
  7. Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure.
  8. 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.
  9. Subject has major valve disease and underwent intervention within 30 days prior to randomization.
  10. Subject has received a heart transplant.
  11. 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):

    1. Most recent LVEF ≤25%, or
    2. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or
    3. Killip class ≥2 (post STEMI patients)
  12. Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only.
  13. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
  14. 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.
  15. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit.
  16. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
  17. Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics.
  18. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amber Dickson 651-202-4135 adickson@csi360.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03108456
Other Study ID Numbers  ICMJE CLN-0011-P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cardiovascular Systems Inc
Study Sponsor  ICMJE Cardiovascular Systems Inc
Collaborators  ICMJE Cardiovascular Research Foundation, New York
Investigators  ICMJE
Principal Investigator: Ajay Kirtane, MD, SM Columbia University Medical Center / New York-Presbyterian Hospital
Principal Investigator: Philippe Généreux, MD Morristown Medical Center
PRS Account Cardiovascular Systems Inc
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP