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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

This study has been completed.
Sponsor:
Information provided by:
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00534859
First received: September 24, 2007
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Patients Undergoing High Risk PCI.
 Device: High Risk PCI
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:
  • MACCE Events at 30 days or discharge, whichever is longer [ Time Frame: 30 days or discharge ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Other intra-procedural and peri-procedural adverse events [ Time Frame: During treatment and out to 90 days ] [ Designated as safety issue: Yes ]
  • Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion [ Time Frame: During procedure ] [ Designated as safety issue: Yes ]

    Freedom from the following procedural-related events:

    i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion


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


Enrollment: 28
Study Start Date: August 2006
Study Completion Date: March 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: High Risk PCI
    High Risk Percutaneous Coronary Intervention
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Brigham & Womens
Boston, Massachusetts, United States, 02115
Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont
Royal Oak, Michigan, United States, 48073
United States, New York
Mt. Sinai School of Medicine
New York, New York, United States, 10029-6574
Columbia Presbyterian Hospital
New York,, New York, United States, 10032
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
  More Information

No publications provided by Abiomed Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc
ClinicalTrials.gov Identifier: NCT00534859     History of Changes
Other Study ID Numbers: G050017
Study First Received: September 24, 2007
Last Updated: March 18, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013