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: Active_not_recruiting
Location: See all (104) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
University of Alabama - Birmingham
Birmingham
Arkansas
Arkansas Heart Hospital
Little Rock
Arizona
Mercy Gilbert Medical Center
Chandler
Arizona Heart Hospital
Phoenix
St. Luke's Medical Center
Phoenix
Yavapai Regional Medical Center
Prescott
California
University of California - San Diego
La Jolla
Cedars-Sinai Medical Center
Los Angeles
Ronald Reagan UCLA Medical Center
Los Angeles
San Francisco VA Medical Center
San Francisco
Colorado
Denver VA Medical Center
Denver
Colorado Heart and Vascular
Lakewood
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
Medstar Washington Hospital Center
Washington
Florida
The Cardiac & Vascular Institute Research Foundation
Gainesville
Memorial Regional Hospital
Hollywood
UF Health Jacksonville
Jacksonville
Heart Institute at Largo
Largo
AdventHealth Ocala
Ocala
Florida Hospital Orlando
Orlando
Palm Beach Gardens Medical Center
Palm Beach Gardens
Tallahassee Research Institute
Tallahassee
St. Joseph's Hospital
Tampa
Georgia
Atlanta VA Medical Center
Atlanta
Piedmont Atlanta Hospital
Atlanta
Northeast Georgia Medical Center
Gainesville
Iowa
Genesis Medical Center
Davenport
Iowa Heart Center
West Des Moines
Illinois
University of Illinos - Chicago
Chicago
Loyola University Medical Center
Maywood
Advocate Christ Medical Center
Oak Lawn
Indiana
Indiana University
Indianapolis
St. Vincent Heart of Indiana
Indianapolis
Community Hospital
Munster
Reid Health
Richmond
Kansas
The University of Kansas Medical Center
Kansas City
Kentucky
U of L Health
Louisville
Louisiana
Baton Rouge General Medical Center
Baton Rouge
Cardiovascular Institute of the South
Houma
Lafayette General Medical Center
Lafayette
Ochsner Medical
New Orleans
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Lahey Clinic
Burlington
University of Massachusetts Worcester
Worcester
Maine
Maine Medical Center
Portland
Michigan
University of Michigan
Ann Arbor
Ascension St. John Hospital and Medical Center
Detroit
Detroit Medical Center
Detroit
Henry Ford Hospital
Detroit
Minnesota
Metropolitan Cardiology Consultants
Coon Rapids
Essentia Health
Duluth
Fairview Southdale Hospital
Edina
Minneapolis Heart Institute
Minneapolis
CentraCare Heart & Vascular Center
Saint Cloud
Missouri
Barnes-Jewish Hospital
Saint Louis
St. Louis University
Saint Louis
VA St. Louis Healthcare System
Saint Louis
Mississippi
Forrest General - Hattiesburg Clinic
Hattiesburg
Stern Cardiovascular
Southaven
North Carolina
University of North Carolina
Chapel Hill
Duke University Medical Center
Durham
Durham VA Medical Center
Durham
WakeMed
Raleigh
Wake Forest Baptist Health
Winston-salem
New Jersey
Deborah Heart and Lung Medical Center
Browns Mills
Hackensack University Medical Center
Hackensack
Morristown Medical Center
Morristown
Newark Beth Israel Medical Center
Newark
New Mexico
New Mexico Heart Institute
Albuquerque
New York
St. Peter's Hospital
Albany
Montefiore-Einstein Medical Center
Bronx
Columbia University Medical Center / New York-Presbyterian Hospital
New York
New York University School of Medicine
New York
Northwell Health
New York
Hudson Valley Cardiovascular Practice, PC
Poughkeepsie
St. Francis Hospital
Roslyn
Ohio
Mercy Health West Hospital
Cincinnati
Cleveland Clinic
Cleveland
University Hospital Cleveland
Cleveland
Riverside Methodist Hospital/Ohio Health
Columbus
Premier Health Specialists
Dayton
Oklahoma
Oklahoma Heart Hospital
Oklahoma City
Oklahoma Heart Hospital - South Campus
Oklahoma City
St. John's Health System
Tulsa
Pennsylvania
Einstein Medical Center
Philadelphia
Penn Presbyterian Medical Center
Philadelphia
Allegheny General Hospital
Pittsburgh
Rhode Island
Rhode Island Hospital
Providence
South Dakota
Sanford Heart Hospital
Sioux Falls
Tennessee
Wellmont CVA Heart Institute
Kingsport
Methodist University Hospital
Memphis
Centennial Medical Center
Nashville
Texas
Dallas VA Medical Center
Dallas
Methodist Health
Dallas
Houston Methodist
Houston
University of Texas Health Science Center at Houston
Houston
University of Texas Health Science Center at San Antonio
San Antonio
Virginia
Sentara Cardiovascular
Norfolk
Washington
Providence Regional Medical Center Everett
Everett
Swedish Medical Center
Seattle
Virginia Mason Medical Center
Seattle
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
West Virginia
Charleston Area Medical Center
Charleston
Time Frame
Start Date: 2017-03-27
Completion Date: 2025-06-12
Participants
Target number of participants: 2005
Treatments
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.
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.
Authors
Christopher Adams, Antonious Attallah, Tomasz Stys, Daniel Sherbet, J. Stephen Jenkins, Gautam Kumar, Robert Feldman, Gautam Gadey, Samip Vasaiwala, Subhash Banerjee, Siddhartha Rao, Thomas Noel, Sahil Banka, Peter Fail, Suresh Sharma, Kevin Croce, Mark Steiner, Claudia Serrano-Gomez, Mark Menegus, Raed Al-Dallow, Robert Wilkins, Thomas McGarry, Brian Bergmark, Ashwani Mehta, Adhir Shroff, Creighton Don, Nicolas Shammas, Jasvindar Singh, Tarek Helmy, Apurva Badheka, Tamim Nazif, Ayman Jamal, Manish Parikh, Giora Weisz, Wilson Ginete, Neerav Shah, Robert Applegate, Naresh Solankhi, Ehtisham Mahmud, Zulfiqar Mirza, Steven Roark, David Lasorda, Brian Jefferson, Eric Roccario, Suhail Allaqaband, Olcay Aksoy, Mansour Assar, Suhail Dohad, Nikolaos Kakouros, Nima Ghasemzadeh, Michael Cleman, Salman Arain, Brian Stegman, Alan Moak, Amit Malhotra, Jesse Klein, Georges Nseir, David Stewart, Rahul Sakhuja, Andrew Sampson, Deepak Talreja, Stevan Himmelstein, Daniel Dulas, Jon George, Amit Goyal, Khaldoon Alaswad, Sarang Mangalmurti, Richard Shlofmitz, Michael Arcarese, Anil Verma, Jaikirshan Khatri, Rohit Bhatheja, Marc Gosselin, John Petersen II, Ziad Jaradat, Monica Hunter, Irfan Admani, Thom Dahle, Mohammad Sarraf, Bruce Lewis, Vincent Varghese, Herbert Aronow, Kintur Sanghvi, Kendrick Shunk, W. Schuyler Jones, Brian Go, Drew Baldwin, Nicholas Hanna, Kishore Harjai, Michael Collins, Manoj Kesarwani, Hiram Bezerra, Geoffrey Kunz, Saihari Sadanandan, Jithendra Choudary, Jordan Safirstein, Naeem Tahirkheli, Rajeev Narayan, Steven Filby, Ankur Lodha, Surendra Avula, Brack Hattler, Craig Frankil, Brigitta Brott, Alpesh Shah, William Suh, Prashant Kaul, John Altman, Aaron Horne, Aravinda Nanjundappa, Rajesh Swaminathan, Sergio Waxman, Ehrin Armstrong, Ron Waksman, Arka Chatterjee, Arthur C Lee, Ammar Nasir
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices
Collaborators: Cardiovascular Research Foundation, New York