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Protect II, A Prospective, Multicenter Randomized Controlled Trial

NCT00562016 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2011-03-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

DEVICE

IABP Intra-aortic balloon pump

IABP uses counterpulsation to provide 0.2L/min coronary flow

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • William O'Neill · Not affilicated with Abiomed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-04-30
Completion
2011-09-30

Countries

  • United States
  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00562016 on ClinicalTrials.gov