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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00534859
First Posted: September 26, 2007
Last Update Posted: March 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abiomed Inc.
September 24, 2007
September 26, 2007
March 21, 2011
August 2006
June 2010   (Final data collection date for primary outcome measure)
  • MACCE Events at 30 days or discharge, whichever is longer [ Time Frame: 30 days or discharge ]
    Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.
  • Freedom from Hemodynamic compromise during PCI procedure [ Time Frame: During procedure ]
    Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required
Not Provided
Complete list of historical versions of study NCT00534859 on ClinicalTrials.gov Archive Site
  • Other intra-procedural and peri-procedural adverse events [ Time Frame: During treatment and out to 90 days ]
  • Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion [ Time Frame: During procedure ]

    Freedom from the following procedural-related events:

    i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion

  • Angiographic Success [ Time Frame: Post-PCI ]
    Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty.
Not Provided
Not Provided
Not Provided
 
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Patients Undergoing High Risk PCI.
Device: High Risk PCI
High Risk Percutaneous Coronary Intervention
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
March 2011
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • ST Myocardial Infarction
  • Cardiac Arrest
  • Cardiogenic Shock
  • Thrombus Left Ventricle
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United States
 
 
NCT00534859
G050017
No
Not Provided
Not Provided
Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc
Abiomed Inc.
Not Provided
Principal Investigator: William O'Neill, M.D. Not affiliated with Abiomed
Abiomed Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP