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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IMPLELLA LP 2.5
IABP Intra-aortic balloon pump
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Patient undergoing scheduled PCI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Mercy Gilbert Medical Center
  • Banner Good Samaritan Medical Center
  • California Cardiovascular/Washington Hospital
  • Foundation for Cardiovascular Medicine
  • University of Southern California
  • University of Miami
  • Munroe Regional Medical Center
  • Emory Crawford Long Hospital
  • Medical College Of Georgia
  • University of Chicago Medical Center
  • Loyola University Medical Center
  • Washington Adventist Hospital
  • Massach General Hospital
  • Brigham & Womens
  • St. Elizabeths Medical Center
  • Oakwood Hospital Wayne State University
  • Henry Ford Medical
  • Harper Hospital
  • St. John Hospital and Medical Center
  • Northern Michigan
  • William Beaumont
  • Providence Hospital and Medical Centers
  • St. Louis University
  • Bryan LGH Heart Institute
  • Morristown Memorial
  • Columbia Presbyterian Hospital
  • Mt. Sinai School of Medicine
  • Strong Memorial Hospital
  • Carolinas Medical Center
  • Duke University Medical Center
  • Cardiovascular Research of Forsythe Medical
  • University of Cincinnati
  • Riverside Methodist
  • UPMC Presbyterian Hospital
  • Robert Packer Hospital
  • Pinnacle Health
  • York Hospital
  • Veteran's Affairs Medical Center Dallas
  • Methodist Hospital
  • University of Texas Medical School at Houston
  • Intermountain Medical Center
  • St. Joseph's Hospital
  • University of Washington
  • Royal Alexandra Hospital
  • University of Alberta Hospital
  • Ottawa Heart Institute
  • Toronto General Hospital
  • Royal Victoria Hospital at McGill
  • Academic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMPELLA LP 2.5

IABP Intra-aortic balloon pump

Arm Description

Outcomes

Primary Outcome Measures

Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2007
Last Updated
March 18, 2011
Sponsor
Abiomed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00562016
Brief Title
Protect II, A Prospective, Multicenter Randomized Controlled Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Futility on primary endpoint.Study confounded by statistically significant differences between the two arms re: atherectomy, duration of support.
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Abiomed Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Patient undergoing scheduled PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMPELLA LP 2.5
Arm Type
Experimental
Arm Title
IABP Intra-aortic balloon pump
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
IMPLELLA LP 2.5
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IABP Intra-aortic balloon pump
Intervention Description
IABP uses counterpulsation to provide 0.2L/min coronary flow
Primary Outcome Measure Information:
Title
Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization.
Time Frame
30 days +/- 10 days
Secondary Outcome Measure Information:
Title
Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP.
Time Frame
In hospital events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William O'Neill
Organizational Affiliation
Not affilicated with Abiomed
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
California Cardiovascular/Washington Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Foundation for Cardiovascular Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Emory Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Medical College Of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Massach General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Womens
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Elizabeths Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Oakwood Hospital Wayne State University
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Henry Ford Medical
City
Detroit
State/Province
Michigan
ZIP/Postal Code
35294
Country
United States
Facility Name
Harper Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
William Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Providence Hospital and Medical Centers
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bryan LGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Morristown Memorial
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Columbia Presbyterian Hospital
City
New York,
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cardiovascular Research of Forsythe Medical
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Riverside Methodist
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Pinnacle Health
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Veteran's Affairs Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
St. Joseph's Hospital
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98198
Country
United States
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H3V9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1Z5
Country
Canada
Facility Name
Royal Victoria Hospital at McGill
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26542494
Citation
Cohen MG, Matthews R, Maini B, Dixon S, Vetrovec G, Wohns D, Palacios I, Popma J, Ohman EM, Schreiber T, O'Neill WW. Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. Am Heart J. 2015 Nov;170(5):872-9. doi: 10.1016/j.ahj.2015.08.009. Epub 2015 Aug 15.
Results Reference
derived
PubMed Identifier
26385039
Citation
Daubert MA, Massaro J, Liao L, Pershad A, Mulukutla S, Magnus Ohman E, Popma J, O'Neill WW, Douglas PS. High-risk percutaneous coronary intervention is associated with reverse left ventricular remodeling and improved outcomes in patients with coronary artery disease and reduced ejection fraction. Am Heart J. 2015 Sep;170(3):550-8. doi: 10.1016/j.ahj.2015.06.013. Epub 2015 Jun 26.
Results Reference
derived
PubMed Identifier
25689546
Citation
Kovacic JC, Kini A, Banerjee S, Dangas G, Massaro J, Mehran R, Popma J, O'Neill WW, Sharma SK. Patients with 3-vessel coronary artery disease and impaired ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II trial. J Interv Cardiol. 2015 Feb;28(1):32-40. doi: 10.1111/joic.12166.
Results Reference
derived
PubMed Identifier
24655695
Citation
Henriques JP, Ouweneel DM, Naidu SS, Palacios IF, Popma J, Ohman EM, O'Neill WW. Evaluating the learning curve in the prospective Randomized Clinical Trial of hemodynamic support with Impella 2.5 versus Intra-Aortic Balloon Pump in patients undergoing high-risk percutaneous coronary intervention: a prespecified subanalysis of the PROTECT II study. Am Heart J. 2014 Apr;167(4):472-479.e5. doi: 10.1016/j.ahj.2013.12.018. Epub 2014 Jan 3.
Results Reference
derived
PubMed Identifier
24527505
Citation
Dangas GD, Kini AS, Sharma SK, Henriques JP, Claessen BE, Dixon SR, Massaro JM, Palacios I, Popma JJ, Ohman M, Stone GW, O'Neill WW. Impact of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump on prognostically important clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (from the PROTECT II randomized trial). Am J Cardiol. 2014 Jan 15;113(2):222-8. doi: 10.1016/j.amjcard.2013.09.008.
Results Reference
derived
PubMed Identifier
22935569
Citation
O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavik V, Popma J, Douglas PS, Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012 Oct 2;126(14):1717-27. doi: 10.1161/CIRCULATIONAHA.112.098194. Epub 2012 Aug 30.
Results Reference
derived

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Protect II, A Prospective, Multicenter Randomized Controlled Trial

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