PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
NCT ID: NCT00534859
Last Updated: 2011-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2006-08-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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High Risk PCI
High Risk Percutaneous Coronary Intervention
Eligibility Criteria
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Inclusion Criteria
* Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
* EF \<35%
Exclusion Criteria
* Cardiac Arrest
* Cardiogenic Shock
* Thrombus Left Ventricle
40 Years
80 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Abiomed Inc
Principal Investigators
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William O'Neill, M.D.
Role: PRINCIPAL_INVESTIGATOR
Not affiliated with Abiomed
Locations
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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
Countries
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References
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Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005.
Other Identifiers
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G050017
Identifier Type: -
Identifier Source: org_study_id
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