Protect II, A Prospective, Multicenter Randomized Controlled Trial

Coronary Artery Disease Clinical Trial

— PROTECT II  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00562016
• Other study ID #: 7182007
• Status: Terminated
• Phase: Phase 3
• First received: November 19, 2007
• Last updated: March 18, 2011
• Start date: October 2007
• Est. completion date: September 2011

Study information

• Verified date: March 2011
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 452
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide 0.2L/min coronary flow

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Royal Victoria Hospital at McGill	Montreal	Quebec
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Netherlands	Academic Medical Center	Amsterdam
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Medical College Of Georgia	Augusta	Georgia
United States	St. Joseph's Hospital	Bellingham	Washington
United States	University of Alabama	Birmingham	Alabama
United States	Brigham & Womens	Boston	Massachusetts
United States	Massach General Hospital	Boston	Massachusetts
United States	St. Elizabeths Medical Center	Boston	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Riverside Methodist	Columbus	Ohio
United States	Veteran's Affairs Medical Center Dallas	Dallas	Texas
United States	Oakwood Hospital Wayne State University	Dearborn	Michigan
United States	Harper Hospital	Detroit	Michigan
United States	Henry Ford Medical	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	California Cardiovascular/Washington Hospital	Fremont	California
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Methodist Hospital	Houston	Texas
United States	University of Texas Medical School at Houston	Houston	Texas
United States	Foundation for Cardiovascular Medicine	La Jolla	California
United States	Bryan LGH Heart Institute	Lincoln	Nebraska
United States	University of Southern California	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Morristown Memorial	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Mt. Sinai School of Medicine	New York	New York
United States	Columbia Presbyterian Hospital	New York,	New York
United States	Munroe Regional Medical Center	Ocala	Florida
United States	Northern Michigan	Petoskey	Michigan
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Strong Memorial Hospital	Rochester	New York
United States	William Beaumont	Royal Oak	Michigan
United States	Robert Packer Hospital	Sayre	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	Providence Hospital and Medical Centers	Southfield	Michigan
United States	St. Louis University	St. Louis	Missouri
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Cardiovascular Research of Forsythe Medical	Winston-Salem	North Carolina
United States	Pinnacle Health	Wormleysburg	Pennsylvania
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.		30 days +/- 10 days	Yes
Secondary	Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.		In hospital events	Yes