Protect II, A Prospective, Multicenter Randomized Controlled Trial
- Conditions
- Coronary Artery Disease
- Interventions
- Device: IMPLELLA LP 2.5Device: IABP Intra-aortic balloon pump
- Registration Number
- NCT00562016
- Lead Sponsor
- Abiomed Inc.
- Brief Summary
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 452
-
Informed consent
-
Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.
-
Patient presents with:
- A compromised Ejection Fraction
- Intervention on the last patent coronary conduit
- Intervention on an unprotected left main artery or
- Patient presenting with triple vessel disease.
- ST elevation M.I.
- Pre procedure cardiac arrest within 24 hours.
- Subject in cardiogenic shock
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMPELLA LP 2.5 IMPLELLA LP 2.5 - IABP Intra-aortic balloon pump IABP Intra-aortic balloon pump -
- Primary Outcome Measures
Name Time Method Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. 30 days +/- 10 days
- Secondary Outcome Measures
Name Time Method Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. In hospital events
Trial Locations
- Locations (50)
Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Bryan LGH Heart Institute
🇺🇸Lincoln, Nebraska, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Massach General Hospital
🇺🇸Boston, Massachusetts, United States
St. Elizabeths Medical Center
🇺🇸Boston, Massachusetts, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
York Hospital
🇺🇸York, Pennsylvania, United States
University of Washington
🇺🇸Seattle, Washington, United States
Medical College Of Georgia
🇺🇸Augusta, Georgia, United States
Foundation for Cardiovascular Medicine
🇺🇸La Jolla, California, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
California Cardiovascular/Washington Hospital
🇺🇸Fremont, California, United States
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Columbia Presbyterian Hospital
🇺🇸New York,, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
University of Southern California
🇺🇸Los Angeles, California, United States
St. Joseph's Hospital
🇺🇸Bellingham, Washington, United States
Riverside Methodist
🇺🇸Columbus, Ohio, United States
Veteran's Affairs Medical Center Dallas
🇺🇸Dallas, Texas, United States
Henry Ford Medical
🇺🇸Detroit, Michigan, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Harper Hospital
🇺🇸Detroit, Michigan, United States
St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cardiovascular Research of Forsythe Medical
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Brigham & Womens
🇺🇸Boston, Massachusetts, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Northern Michigan
🇺🇸Petoskey, Michigan, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States
Pinnacle Health
🇺🇸Wormleysburg, Pennsylvania, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
William Beaumont
🇺🇸Royal Oak, Michigan, United States
Morristown Memorial
🇺🇸Morristown, New Jersey, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Providence Hospital and Medical Centers
🇺🇸Southfield, Michigan, United States
Royal Victoria Hospital at McGill
🇨🇦Montreal, Quebec, Canada
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Oakwood Hospital Wayne State University
🇺🇸Dearborn, Michigan, United States