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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)

Primary Purpose

Coronary Artery Disease, Ischemic Heart Disease, Non ST Segment Elevation Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orbital Atherectomy
Balloon
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring atherectomy, CAD, severe calcium, orbital atherectomy, minimum stent area

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama - Birmingham
  • Mercy Gilbert Medical Center
  • St. Luke's Medical Center
  • Arizona Heart Hospital
  • Yavapai Regional Medical Center
  • Arkansas Heart Hospital
  • University of California - San Diego
  • Cedars-Sinai Medical Center
  • Ronald Reagan UCLA Medical Center
  • San Francisco VA Medical Center
  • Denver VA Medical Center
  • Colorado Heart and Vascular
  • Yale New Haven Hospital
  • Medstar Washington Hospital Center
  • The Cardiac & Vascular Institute Research Foundation
  • Memorial Regional Hospital
  • UF Health Jacksonville
  • Heart Institute at Largo
  • AdventHealth Ocala
  • Florida Hospital Orlando
  • Palm Beach Gardens Medical Center
  • Tallahassee Research Institute
  • St. Joseph's Hospital
  • Atlanta VA Medical Center
  • Piedmont Atlanta Hospital
  • Northeast Georgia Medical Center
  • University of Illinos - Chicago
  • Loyola University Medical Center
  • Advocate Christ Medical Center
  • Indiana University
  • St. Vincent Heart of Indiana
  • Community Hospital
  • Reid Health
  • Genesis Medical Center
  • Iowa Heart Center
  • The University of Kansas Medical Center
  • U of L Health
  • Baton Rouge General Medical Center
  • Cardiovascular Institute of the South
  • Lafayette General Medical Center
  • Ochsner Medical
  • Maine Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Lahey Clinic
  • University of Massachusetts Worcester
  • University of Michigan
  • Detroit Medical Center
  • Henry Ford Hospital
  • Ascension St. John Hospital and Medical Center
  • Metropolitan Cardiology Consultants
  • Essentia Health
  • Fairview Southdale Hospital
  • Minneapolis Heart Institute
  • CentraCare Heart & Vascular Center
  • Forrest General - Hattiesburg Clinic
  • Stern Cardiovascular
  • VA St. Louis Healthcare System
  • Barnes-Jewish Hospital
  • St. Louis University
  • Deborah Heart and Lung Medical Center
  • Hackensack University Medical Center
  • Morristown Medical Center
  • Newark Beth Israel Medical Center
  • New Mexico Heart Institute
  • St. Peter's Hospital
  • Montefiore-Einstein Medical Center
  • New York University School of Medicine
  • Columbia University Medical Center / New York-Presbyterian Hospital
  • Northwell Health
  • Hudson Valley Cardiovascular Practice, PC
  • St. Francis Hospital
  • University of North Carolina
  • Duke University Medical Center
  • Durham VA Medical Center
  • WakeMed
  • Wake Forest Baptist Health
  • Mercy Health West Hospital
  • University Hospital Cleveland
  • Cleveland Clinic
  • Riverside Methodist Hospital/Ohio Health
  • Premier Health Specialists
  • Oklahoma Heart Hospital - South Campus
  • Oklahoma Heart Hospital
  • St. John's Health System
  • Penn Presbyterian Medical Center
  • Einstein Medical Center
  • Allegheny General Hospital
  • Rhode Island Hospital
  • Sanford Heart Hospital
  • Wellmont CVA Heart Institute
  • Methodist University Hospital
  • Centennial Medical Center
  • Methodist Health
  • Dallas VA Medical Center
  • Houston Methodist
  • University of Texas Health Science Center at Houston
  • University of Texas Health Science Center at San Antonio
  • Sentara Cardiovascular
  • Providence Regional Medical Center Everett
  • Virginia Mason Medical Center
  • Swedish Medical Center
  • Charleston Area Medical Center
  • Aurora St. Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Orbital Atherectomy (OA)

Conventional Balloon Angioplasty

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Acute Minimum Stent Area (MSA)
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)
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

Procedural Success
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
Strategy success, defined as procedural success without crossover to alternative treatment.

Full Information

First Posted
February 17, 2017
Last Updated
October 5, 2023
Sponsor
Abbott Medical Devices
Collaborators
Cardiovascular Research Foundation, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03108456
Brief 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
Acronym
ECLIPSE
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
June 12, 2024 (Anticipated)
Study Completion Date
June 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Cardiovascular Research Foundation, New York

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemic Heart Disease, Non ST Segment Elevation Myocardial Infarction
Keywords
atherectomy, CAD, severe calcium, orbital atherectomy, minimum stent area

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2005 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orbital Atherectomy (OA)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Balloon Angioplasty
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Orbital Atherectomy
Intervention Description
Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Intervention Type
Device
Intervention Name(s)
Balloon
Intervention Description
Vessel preparation with conventional and/or specialty balloons
Primary Outcome Measure Information:
Title
Acute Minimum Stent Area (MSA)
Description
In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT) at the conclusion of the procedure in the OCT imaging cohort.
Time Frame
Procedure
Title
Target Vessel Failure (TVF)
Description
Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.
Time Frame
1-Year
Secondary Outcome Measure Information:
Title
Procedural Success
Description
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.
Time Frame
Procedure
Title
Strategy Success
Description
Strategy success, defined as procedural success without crossover to alternative treatment.
Time Frame
Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria: Subject is 18 years of age or older. 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) 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. Subject is participating in or has plans to participate in any other investigational drug or device trial that has not reached its primary endpoint. Subject is a female who is pregnant. Subject is receiving or scheduled to receive chemotherapy within thirty (30) days prior or any time after the randomization procedure. Subject has a life expectancy of ≤ 12 months. Subject has undergone any prior PCI in the target vessel or its branches 12 months prior to randomization. Subject has undergone a PCI procedure that is unsuccessful or with complications within 30 days prior to randomization, including during the randomization procedure. 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. Subject has major valve disease and underwent intervention within 30 days prior to randomization. Subject has received a heart transplant. 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) Planned use in the randomized lesion(s) of a bare metal stent (BMS), bioresorbable scaffold (BRS), non-stent treatment only. Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated. 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. Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit. Subject has a history of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary. Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics. Subject with known allergy to atherectomy lubricant components including soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Kirtane, MD, SM
Organizational Affiliation
Columbia University Medical Center / New York-Presbyterian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Généreux, MD
Organizational Affiliation
Morristown Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mercy Gilbert Medical Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
St. Luke's Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Yavapai Regional Medical Center
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
University of California - San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
942121
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Colorado Heart and Vascular
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
The Cardiac & Vascular Institute Research Foundation
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Heart Institute at Largo
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
AdventHealth Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Palm Beach Gardens Medical Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Atlanta VA Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
University of Illinos - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Heart of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
U of L Health
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Lafayette General Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Ochsner Medical
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04021
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Massachusetts Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Ascension St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Metropolitan Cardiology Consultants
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Essentia Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
CentraCare Heart & Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Forrest General - Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Stern Cardiovascular
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
VA St. Louis Healthcare System
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Deborah Heart and Lung Medical Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
St. Peter's Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore-Einstein Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center / New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Hudson Valley Cardiovascular Practice, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
WakeMed
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
Facility Name
Mercy Health West Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Facility Name
University Hospital Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital/Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Premier Health Specialists
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Oklahoma Heart Hospital - South Campus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73119
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
St. John's Health System
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Sanford Heart Hospital
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Methodist Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sentara Cardiovascular
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35288105
Citation
Genereux P, Kirtane AJ, Kandzari DE, Armstrong EJ, Krucoff MW, Redfors B, Ben-Yehuda O, Lerew DR, Ali ZA, Maehara A, O'Neill WW, Stone GW. Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial. Am Heart J. 2022 Jul;249:1-11. doi: 10.1016/j.ahj.2022.03.003. Epub 2022 Mar 12.
Results Reference
background

Learn more about this trial

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

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