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
Location: See all (113) 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: No
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
Central Research Associates Inc/St. Vincent's Hospital Birmingham
Withdrawn
Birmingham
University of Alabama - Birmingham
Completed
Birmingham
Arkansas
Arkansas Heart Hospital
Recruiting
Little Rock
Arizona
Mercy Gilbert Medical Center
Recruiting
Chandler
Arizona Heart Hospital
Completed
Phoenix
St. Luke's Medical Center
Terminated
Phoenix
Yavapai Regional Medical Center
Active, not recruiting
Prescott
California
University of California - San Diego
Recruiting
La Jolla
Cedars-Sinai Medical Center
Recruiting
Los Angeles
Ronald Reagan UCLA Medical Center
Recruiting
Los Angeles
University of California - Davis
Withdrawn
Sacramento
San Francisco VA Medical Center
Recruiting
San Francisco
Torrance Memorial Medical Center
Withdrawn
Torrance
Colorado
Denver VA Medical Center
Active, not recruiting
Denver
Colorado Heart and Vascular
Recruiting
Lakewood
Connecticut
Yale New Haven Hospital
Recruiting
New Haven
Washington, D.c.
Medstar Washington Hospital Center
Recruiting
Washington
Florida
The Cardiac & Vascular Institute Research Foundation
Recruiting
Gainesville
Memorial Regional Hospital
Active, not recruiting
Hollywood
UF Health Jacksonville
Recruiting
Jacksonville
Heart Institute at Largo
Active, not recruiting
Largo
AdventHealth Ocala
Recruiting
Ocala
Florida Hospital Orlando
Recruiting
Orlando
Orlando Health
Withdrawn
Orlando
Palm Beach Gardens Medical Center
Completed
Palm Beach Gardens
Tallahassee Research Institute
Recruiting
Tallahassee
St. Joseph's Hospital
Active, not recruiting
Tampa
Georgia
Atlanta VA Medical Center
Recruiting
Atlanta
Piedmont Atlanta Hospital
Recruiting
Atlanta
Northeast Georgia Medical Center
Recruiting
Gainesville
Iowa
Genesis Medical Center
Recruiting
Davenport
Iowa Heart Center
Completed
West Des Moines
Illinois
Memorial Hospital of Carbondale
Withdrawn
Carbondale
University of Illinos - Chicago
Recruiting
Chicago
Loyola University Medical Center
Recruiting
Maywood
Advocate Christ Medical Center
Completed
Oak Lawn
Indiana
Indiana University
Completed
Indianapolis
St. Vincent Heart of Indiana
Completed
Indianapolis
Community Hospital
Recruiting
Munster
Reid Health
Recruiting
Richmond
Kansas
The University of Kansas Medical Center
Completed
Kansas City
Kentucky
U of L Health
Recruiting
Louisville
Louisiana
Baton Rouge General Medical Center
Recruiting
Baton Rouge
Cardiovascular Institute of the South
Completed
Houma
Lafayette General Medical Center
Recruiting
Lafayette
Ochsner Medical
Active, not recruiting
New Orleans
Massachusetts
Brigham and Women's Hospital
Recruiting
Boston
Massachusetts General Hospital
Recruiting
Boston
Lahey Clinic
Recruiting
Burlington
University of Massachusetts Worcester
Recruiting
Worcester
Maine
Maine Medical Center
Active, not recruiting
Portland
Michigan
University of Michigan
Recruiting
Ann Arbor
Ascension St. John Hospital and Medical Center
Completed
Detroit
Detroit Medical Center
Terminated
Detroit
Henry Ford Hospital
Recruiting
Detroit
Minnesota
Metropolitan Cardiology Consultants
Recruiting
Coon Rapids
Essentia Health
Recruiting
Duluth
Fairview Southdale Hospital
Completed
Edina
Minneapolis Heart Institute
Recruiting
Minneapolis
CentraCare Heart & Vascular Center
Recruiting
Saint Cloud
Missouri
Barnes-Jewish Hospital
Recruiting
Saint Louis
St. Louis University
Recruiting
Saint Louis
VA St. Louis Healthcare System
Recruiting
Saint Louis
Mississippi
Forrest General - Hattiesburg Clinic
Recruiting
Hattiesburg
Stern Cardiovascular
Completed
Southaven
North Carolina
University of North Carolina
Recruiting
Chapel Hill
Duke University Medical Center
Recruiting
Durham
Durham VA Medical Center
Recruiting
Durham
WakeMed
Completed
Raleigh
Wake Forest Baptist Health
Recruiting
Winston-salem
New Jersey
Deborah Heart and Lung Medical Center
Recruiting
Browns Mills
Hackensack University Medical Center
Completed
Hackensack
Morristown Medical Center
Recruiting
Morristown
Newark Beth Israel Medical Center
Recruiting
Newark
New Mexico
New Mexico Heart Institute
Completed
Albuquerque
New York
St. Peter's Hospital
Recruiting
Albany
Montefiore-Einstein Medical Center
Active, not recruiting
Bronx
Columbia University Medical Center / New York-Presbyterian Hospital
Recruiting
New York
New York University School of Medicine
Recruiting
New York
Northwell Health
Active, not recruiting
New York
Hudson Valley Cardiovascular Practice, PC
Active, not recruiting
Poughkeepsie
St. Francis Hospital
Recruiting
Roslyn
Ohio
Mercy Health West Hospital
Recruiting
Cincinnati
Cleveland Clinic
Completed
Cleveland
University Hospital Cleveland
Active, not recruiting
Cleveland
Riverside Methodist Hospital/Ohio Health
Active, not recruiting
Columbus
Premier Health Specialists
Completed
Dayton
Kettering Medical Center
Withdrawn
Kettering
Oklahoma
Oklahoma Heart Hospital
Completed
Oklahoma City
Oklahoma Heart Hospital - South Campus
Recruiting
Oklahoma City
St. John's Health System
Recruiting
Tulsa
Pennsylvania
Bryn Mawr Hospital
Withdrawn
Bryn Mawr
Einstein Medical Center
Recruiting
Philadelphia
Penn Presbyterian Medical Center
Recruiting
Philadelphia
Allegheny General Hospital
Recruiting
Pittsburgh
Rhode Island
Rhode Island Hospital
Active, not recruiting
Providence
South Dakota
Sanford Heart Hospital
Completed
Sioux Falls
Tennessee
Wellmont CVA Heart Institute
Completed
Kingsport
Methodist University Hospital
Completed
Memphis
Centennial Medical Center
Active, not recruiting
Nashville
Texas
Dallas VA Medical Center
Active, not recruiting
Dallas
Methodist Health
Terminated
Dallas
Houston Methodist
Recruiting
Houston
University of Texas Health Science Center at Houston
Recruiting
Houston
University of Texas Health Science Center at San Antonio
Completed
San Antonio
Virginia
Sentara Cardiovascular
Recruiting
Norfolk
Chippenham Hospital
Withdrawn
Richmond
Washington
Providence Regional Medical Center Everett
Recruiting
Everett
Swedish Medical Center
Recruiting
Seattle
University of Washington
Withdrawn
Seattle
Virginia Mason Medical Center
Completed
Seattle
Wisconsin
Aurora St. Luke's Medical Center
Recruiting
Milwaukee
West Virginia
Charleston Area Medical Center
Completed
Charleston
Contact Information
Primary
Krista Steifel
kstiefel@csi360.com
651-900-6671
Time Frame
Start Date: March 27, 2017
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 2000
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
P. Michael Grossman, Tim Biring, Antonious Attallah, Tomasz Stys, Daniel Sherbet, J. Stephen Jenkins, Gautam Kumar, Robert Feldman, Gautam Gadey, Samip Vasaiwala, Joseph Rossi, Subhash Banerjee, John Peterson II, Siddhartha Rao, Kevin Croce, Thomas Noel, Sahil Banka, Peter Fail, Aravinda Nanjundappa, Sergio Waxman, Suresh Sharma, Mark Steiner, Mark Menegus, W. Schuyler Jones, Brian Bergmark, Ashwani Mehta, Adhir Shroff, Creighton Don, Prashant Kaul, Rajesh Swaminathan, Ron Waksman, Philippe Généreux, Jasvindar Singh, Tarek Helmy, Apurva Badheka, Arthur C Lee, Tamim Nazif, Ayman Jamal, Manish Parikh, Giora Weisz, Wilson Ginete, Neerav Shah, Naresh Solankhi, Thomas McGarry, Amir Kaki, Ivan Chavez, Ehtisham Mahmud, Zulfiqar Mirza, Steven Roark, Arka Chatterjee, John Altman, David Lasorda, Ajay Kirtane, Craig Thompson, Brian Jefferson, Eric Roccario, Suhail Allaqaband, Olcay Aksoy, Mansour Assar, Suhail Dohad, Nikolaos Kakouros, David Stewart, Nima Ghasemzadeh, Michael Cleman, Salman Arain, Brian Stegman, Alan Moak, Amit Malhotra, Jesse Klein, Georges Nseir, Rahul Sakhuja, Andrew Sampson, Deepak Talreja, Stevan Himmelstein, Daniel Dulas, Jon George, Khaldoon Alaswad, Sarang Mangalmurti, Richard Shlofmitz, Michael Arcarese, Rohit Bhatheja, Marc Gosselin, Ziad Jaradat, Anil Verma, Monica Hunter, Irfan Admani, Thom Dahle, Mohammad Sarraf, Juan Pastor, Robert Wilkins, Ehrin Armstrong, Vincent Varghese, Herbert Aronow, Kintur Sanghvi, Ammar Nasir, Kendrick Shunk, Brian Go, Drew Baldwin, Satish Gadi, Nicholas Hanna, Kishore Harjai, Manoj Kesarwani, Hiram Bezerra, Magdi Ghali, Geoffrey Kunz, Saihari Sadanandan, Jithendra Choudary, Jordan Safirstein, Naeem Tahirkheli, Rajeev Narayan, Steven Filby, Richard Heuser, Aaron Horne, Ankur Lodha, Michael Collins, Surendra Avula, Brack Hattler, Craig Frankil, Brigitta Brott, Alpesh Shah, Raed Al-Dallow, Claudia Serrano-Gomez, William Suh, D. Chris Metzger, Shah Hinan Ahmed, R. Michael Wyman, Amit Goyal, Bruce Lewis, Robert Applegate, Nicolas Shammas, Pradyumma Tummala, M. Niranjan Reddy, Carlos Sanchez, Jaikirshan Khatri, Michael Kim, Adhir Schroff, John Petersen II, Christopher Adams, Andres Pineda
Sponsors
Leads: Cardiovascular Systems Inc
Collaborators: Cardiovascular Research Foundation, New York

This content was sourced from clinicaltrials.gov

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