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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 : July 10, 2019
Sponsor:
Collaborator:
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
Cardiovascular Systems Inc

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).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
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.
Device: Balloon
Vessel preparation with conventional and/or specialty balloons




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Criteria

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) 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 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 (note - Left Ventricular Ejection Fraction [LVEF] is not required by protocol):

    1. Most recent LVEF ≤25%, or
    2. Current heart failure defined as NYHA class ≥3 (all patients) or 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 aspirin or all P2Y12 inhibitor agents, or will be unable to take both aspirin and a P2Y12 inhibitor for at least 6 months after PCI (e.g., due to a planned surgical procedure).
  15. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months, 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 is not an acceptable candidate for emergent coronary artery bypass graft (CABG).
  19. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.

Information from the National Library of Medicine

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


Contacts
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Contact: Amber Dickson 651-202-4135 adickson@csi360.com

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Sponsors and Collaborators
Cardiovascular Systems Inc
Cardiovascular Research Foundation, New York
Investigators
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Principal Investigator: Ajay Kirtane, MD, SM Columbia University Medical Center / New York-Presbyterian Hospital
Principal Investigator: Philippe Généreux, MD Morristown Medical Center

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Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT03108456     History of Changes
Other Study ID Numbers: CLN-0011-P
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Cardiovascular Systems Inc:
atherectomy
CAD
severe calcium
orbital atherectomy
minimum stent area

Additional relevant MeSH terms:
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Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases