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

March 18, 2011 updated by: Abiomed Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

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

  • Netherlands
    • Netherland
      • Amsterdam, Netherland, Netherlands
        • Academic Medical Center
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Womens
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont
    • 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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
    • Texas
      • Houston, Texas, United States, 777030
        • Texas Heart

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

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days or discharge
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
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other intra-procedural and peri-procedural adverse events
Time Frame: During treatment and out to 90 days
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
During procedure
Angiographic Success
Time Frame: Post-PCI
Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty.
Post-PCI

Collaborators and Investigators

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

Sponsor

Abiomed Inc.

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

August 1, 2006

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (ESTIMATE)

September 26, 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

Other Study ID Numbers

  • G050017

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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