Protect II, A Prospective, Multicenter Randomized Controlled Trial

Phase 3

Terminated

• Conditions: Coronary Artery Disease

• Registration Number: NCT00562016
• Lead Sponsor: Abiomed Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-18
• Last Update Posted: 2011-03-21
• Primary Completion: 2011-04
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 452

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.	In hospital events

Trial Locations

Locations (50)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Mercy Gilbert Medical Center; 🇺🇸 Gilbert, Arizona, United States

Banner Good Samaritan Medical Center; 🇺🇸 Phoenix, Arizona, United States

California Cardiovascular/Washington Hospital; 🇺🇸 Fremont, California, United States

Foundation for Cardiovascular Medicine; 🇺🇸 La Jolla, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Munroe Regional Medical Center; 🇺🇸 Ocala, Florida, United States

Emory Crawford Long Hospital; 🇺🇸 Atlanta, Georgia, United States

Medical College Of Georgia; 🇺🇸 Augusta, Georgia, United States

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