Protect II, A Prospective, Multicenter Randomized Controlled Trial (PROTECT II)

March 18, 2011 updated by: Abiomed Inc.

PROTECT II: A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP)in Patients Undergoing Non Emergent High Risk PCI

The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

452

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, t6g2b7
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T5H3V9
        • Royal Alexandra Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4W7
        • Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5G1Z5
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • Royal Victoria Hospital at McGill
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University Of Alabama
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Medical Center
    • California
      • Fremont, California, United States, 94538
        • California Cardiovascular/Washington Hospital
      • La Jolla, California, United States, 92037
        • Foundation for Cardiovascular Medicine
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Ocala, Florida, United States, 34471
        • Munroe Regional Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Crawford Long Hospital
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Maryland
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Womens
      • Boston, Massachusetts, United States, 02114
        • Massach General Hospital
      • Boston, Massachusetts, United States, 02135
        • St. Elizabeths Medical Center
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Oakwood Hospital Wayne State University
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
      • Detroit, Michigan, United States, 48201
        • Harper Hospital
      • Detroit, Michigan, United States, 35294
        • Henry Ford Medical
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont
      • Southfield, Michigan, United States, 48075
        • Providence Hospital and Medical Centers
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • St. Louis University
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan LGH Heart Institute
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial
    • New York
      • New York, New York, United States, 10029-6574
        • Mt. Sinai School of Medicine
      • New York,, New York, United States, 10032
        • Columbia Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Cardiovascular Research of Forsythe Medical
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • Texas
      • Dallas, Texas, United States, 75216
        • Veteran's Affairs Medical Center Dallas
      • Houston, Texas, United States, 77030
        • University of Texas Medical School at Houston
      • Houston, Texas, United States, 77030
        • Methodist Hospital
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
    • Washington
      • Bellingham, Washington, United States, 98225
        • St. Joseph's Hospital
      • Seattle, Washington, United States, 98198
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.

  • Patient presents with:

    • A compromised Ejection Fraction
    • Intervention on the last patent coronary conduit
    • Intervention on an unprotected left main artery or
    • Patient presenting with triple vessel disease.

Exclusion Criteria:

  • ST elevation M.I.
  • Pre procedure cardiac arrest within 24 hours.
  • Subject in cardiogenic shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IMPELLA LP 2.5
Device: IMPLELLA LP 2.5
Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5 L/min.
ACTIVE_COMPARATOR: IABP Intra-aortic balloon pump
Device: IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide 0.2L/min coronary flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
Time Frame: 30 days +/- 10 days
30 days +/- 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.
Time Frame: In hospital events
In hospital events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Investigators

  • Principal Investigator: William O'Neill, Not affilicated with Abiomed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (ESTIMATE)

November 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2011

Last Update Submitted That Met QC Criteria

March 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7182007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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