PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

Completed · Phase 2

Conditions studied: Patients Undergoing High Risk PCI.

In brief

The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.

Key facts

Study ID

NCT00534859

Run by

Abiomed Inc.

People needed

28

Starts

2006-08-01

Expected to finish

2011-03-01

Last updated by the study team

2011-03-21

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent
• Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
• EF <35%

You may not qualify if…

• ST Myocardial Infarction
• Cardiac Arrest
• Cardiogenic Shock
• Thrombus Left Ventricle

Where it is running

• Scripps — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Mass General Hospital — Boston, Massachusetts, United States
• Brigham & Womens — Boston, Massachusetts, United States
• William Beaumont — Royal Oak, Michigan, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Columbia Presbyterian Hospital — New York, New York, United States
• UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
• Texas Heart — Houston, Texas, United States
• Academic Medical Center — Amsterdam, Netherland, Netherlands

Full record on ClinicalTrials.gov

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