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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 27, 2017
End Date:December 31, 2021
Contact:Amber Dickson
Email:adickson@csi360.com
Phone:651-202-4135

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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).


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.
We found this trial at
100
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Drew Baldwin, MD
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Kevin Croce, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Jaikirshan Khatri, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Ziad Jaradat, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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8700 Beverly Blvd # 8211
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Principal Investigator: Suhail Dohad, MD
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24 Sturtevant St
Orlando, Florida 32806
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22 Bramhall St
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593 Eddy Street
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2160 South 1st Avenue
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20 York St, N20 York St,
New Haven, Connecticut 06520
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1514 Jefferson Highway
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