This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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.
Information provided by:
Abiomed Inc. Identifier:
First received: September 24, 2007
Last updated: March 18, 2011
Last verified: March 2011
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
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

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 ]
    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

Secondary Outcome Measures:
  • 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.

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00534859

United States, California
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
Academic Medical Center
Amsterdam, Netherland, Netherlands
Sponsors and Collaborators
Abiomed Inc.
Principal Investigator: William O'Neill, M.D. Not affiliated with Abiomed
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc Identifier: NCT00534859     History of Changes
Other Study ID Numbers: G050017
Study First Received: September 24, 2007
Last Updated: March 18, 2011 processed this record on September 21, 2017