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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)

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ClinicalTrials.gov Identifier: NCT00534859
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : March 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patients Undergoing High Risk PCI. Device: High Risk PCI Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
Study Start Date : August 2006
Primary Completion Date : June 2010
Study Completion Date : March 2011
Arms and Interventions

Intervention Details:
    Device: High Risk PCI
    High Risk Percutaneous Coronary Intervention

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Other intra-procedural and peri-procedural adverse events [ Time Frame: During treatment and out to 90 days ]
  2. 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


  3. Angiographic Success [ Time Frame: Post-PCI ]
    Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534859


Locations
United States, California
Scripps
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Womens
Boston, Massachusetts, United States, 02115
United States, Michigan
William Beaumont
Royal Oak, Michigan, United States, 48073
United States, New York
Columbia Presbyterian Hospital
New York,, New York, United States, 10032
Mt. Sinai School of Medicine
New York, New York, United States, 10029-6574
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Texas Heart
Houston, Texas, United States, 777030
Netherlands
Academic Medical Center
Amsterdam, Netherland, Netherlands
Sponsors and Collaborators
Abiomed Inc.
Investigators
Principal Investigator: William O'Neill, M.D. Not affiliated with Abiomed