Protect II, A Prospective, Multicenter Randomized Controlled Trial

Stopped early · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00562016

Run by

Abiomed Inc.

People needed

452

Starts

2007-10-01

Expected to finish

2011-09-01

Last updated by the study team

2011-03-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• ST elevation M.I.
• Pre procedure cardiac arrest within 24 hours.
• Subject in cardiogenic shock

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• California Cardiovascular/Washington Hospital — Fremont, California, United States
• Foundation for Cardiovascular Medicine — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of Miami — Miami, Florida, United States
• Munroe Regional Medical Center — Ocala, Florida, United States
• Emory Crawford Long Hospital — Atlanta, Georgia, United States
• Medical College Of Georgia — Augusta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Massach General Hospital — Boston, Massachusetts, United States
• Brigham & Womens — Boston, Massachusetts, United States
• St. Elizabeths Medical Center — Boston, Massachusetts, United States
• Oakwood Hospital Wayne State University — Dearborn, Michigan, United States
• Henry Ford Medical — Detroit, Michigan, United States
• Harper Hospital — Detroit, Michigan, United States
• St. John Hospital and Medical Center — Detroit, Michigan, United States
• Northern Michigan — Petoskey, Michigan, United States
• William Beaumont — Royal Oak, Michigan, United States
• Providence Hospital and Medical Centers — Southfield, Michigan, United States
• St. Louis University — St Louis, Missouri, United States
• Bryan LGH Heart Institute — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.