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 |
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).
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
sites
41 Mall Road
Burlington, Massachusetts 1805
Burlington, Massachusetts 1805
781-744-5100
![Lahey Clinic](/wp-content/uploads/logos/lahey-clinic.jpg)
Principal Investigator: Gautam Gadey, MD
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
![University of Alabama at Birmingham](/wp-content/uploads/logos/university-of-alabama-at-birmingham.jpg)
Principal Investigator: Mohammad Sarraf, MD
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
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Principal Investigator: Kevin Croce, MD
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9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
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Principal Investigator: Jaikirshan Khatri, MD
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425 University Blvd.
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-4591
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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
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
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Principal Investigator: Suhail Dohad, MD
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22 Bramhall St
Portland, Maine 04102
Portland, Maine 04102
(207) 662-0111
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
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Seattle, Washington 98104
(206) 543-2100
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
![University of Michigan](/wp-content/uploads/logos/university-of-michigan.jpg)
Principal Investigator: P. Michael Grossman, MD
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303 Parkway Drive Northeast
Atlanta, Georgia 30033
Atlanta, Georgia 30033
Principal Investigator: Gautam Kumar, MD
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Birmingham, Alabama 35205
Principal Investigator: Monica Hunter, MD
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111 East 210th Street
Bronx, New York 10467
Bronx, New York 10467
Principal Investigator: Giora Weisz, MD
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Browns Mills, New Jersey 08015
Principal Investigator: Kintur Sanghvi, MD
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
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Carbondale, Illinois 62902
Principal Investigator: Raed Al-Dallow, MD
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3555 South Val Vista Drive
Chandler, Arizona 85224
Chandler, Arizona 85224
Principal Investigator: Georges Nseir, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
![Univ of North Carolina](/wp-content/uploads/logos/univ-of-north-carolina.png)
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Charleston, West Virginia 25304
Principal Investigator: Aravinda Nanjundappa, MD
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Columbus, Ohio 43214
Principal Investigator: Carlos Sanchez, MD
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Coon Rapids, Minnesota 55433
Principal Investigator: Daniel Dulas, MD
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4500 S. Lancaster Rd.
Dallas, Texas 75216
Dallas, Texas 75216
800-849-3597
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1441 North Beckley Avenue
Dallas, Texas 75203
Dallas, Texas 75203
Principal Investigator: Aaron Horne, MD
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22101 Moross Road
Detroit, Michigan 48236
Detroit, Michigan 48236
Principal Investigator: Marc Gosselin, DO
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(313) 916-2600
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Principal Investigator: Khaldoon Alaswad, MD
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
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Principal Investigator: W. Schuyler Jones, MD
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508 Fulton Street
Durham, North Carolina 27705
Durham, North Carolina 27705
919-286-0411
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Principal Investigator: Rajesh Swaminathan, MD
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6401 France Ave S
Edina, Minnesota 55435
Edina, Minnesota 55435
(952) 924-5000
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Gainesville, Florida 32605
Principal Investigator: Arthur C Lee, MD
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743 Spring St NE
Gainesville, Georgia 30501
Gainesville, Georgia 30501
770-219-9000
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Principal Investigator: Pradyumma Tummala, MD
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
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Principal Investigator: Irfan Admani, MD
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Hattiesburg, Mississippi 39401
Principal Investigator: Robert Wilkins, MD
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
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Principal Investigator: Ashwani Mehta, MD
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3535 Southern Blvd
Kettering, Ohio 45429
Kettering, Ohio 45429
(937) 298-4331
![Kettering Medical Center](/wp-content/uploads/logos/kettering-medical-center.png)
Principal Investigator: M. Niranjan Reddy, MD
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Kingsport, Tennessee 37660
Principal Investigator: D. Chris Metzger, MD
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9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
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Principal Investigator: Ehtisham Mahmud, MD
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Los Angeles, California 90095
Principal Investigator: William Suh, MD
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
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Principal Investigator: Bruce Lewis, MD
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Memphis, Tennessee 38104
Principal Investigator: Stevan Himmelstein, MD
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
414-649-6000
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Morristown, New Jersey 07962
Principal Investigator: Jordan Safirstein, MD
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20 York St, N20 York St,
New Haven, Connecticut 06520
New Haven, Connecticut 06520
(203) 688-4242
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Principal Investigator: Michael Cleman, MD
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1514 Jefferson Highway
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Principal Investigator: J. Stephen Jenkins, MD
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New York, New York 10032
Principal Investigator: Manish Parikh, MD
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450 Lakeville Road
New York, New York 11042
New York, New York 11042
Principal Investigator: Michael Kim, MD
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4440 West 95th Street
Oak Lawn, Illinois 60453
Oak Lawn, Illinois 60453
708.684.8000
![Advocate Christ Medical Center](/wp-content/uploads/logos/advocate-christ-medical-center.gif)
Principal Investigator: Surendra Avula, MD
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Palm Beach Gardens, Florida 33410
Principal Investigator: Neerav Shah, MD
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320 E North Ave
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
(412) 359-3131
![Allegheny General Hospital](/wp-content/uploads/logos/allegheny-general-hospital.png)
Principal Investigator: David Lasorda, DO
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Poughkeepsie, New York 12601
Principal Investigator: Rajeev Narayan, MD
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1 Shields Ave
Sacramento, California 95616
Sacramento, California 95616
(530) 752-1011
![University of California-Davis](/wp-content/uploads/logos/university-of-california-davis.png)
Principal Investigator: Manoj Kesarwani, MD
University of California-Davis As we begin our second century, UC Davis is poised to become...
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Principal Investigator: Thom Dahle, MD
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San Francisco, California 94121
Principal Investigator: Kendrick Shunk, MD
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5300 Tallman Ave NW
Seattle, Washington 98122
Seattle, Washington 98122
(206) 782-2700
![Swedish Medical Center](/wp-content/uploads/logos/swedish-medical-center.png)
Principal Investigator: John Peterson II, MD
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Seattle, Washington 98101
(888) 862-2737
![Virginia Mason Medical Center](/wp-content/uploads/logos/virginia-mason-medical-center.jpg)
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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Torrance, California 90505
Principal Investigator: R. Michael Wyman, MD
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Washington, District of Columbia
Principal Investigator: Ron Waksman, MD
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Winston-Salem, North Carolina 27157
Principal Investigator: Robert Applegate, MD
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Worcester, Massachusetts 01655
Principal Investigator: Nikolaos Kakouros, MD
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