TerminatedNCT00562016PROTECT IIUpdated Mar 21, 2011

Protect II, A Prospective, Multicenter Randomized Controlled Trial

A Phase 3 interventional study of IMPLELLA LP 2.5 and IABP Intra-aortic balloon pump in Coronary Artery Disease, sponsored by Abiomed Inc.. Terminated at 50 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-03-21.

Sponsored by Abiomed Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated

Futility on primary endpoint.Study confounded by statistically significant differences between the two arms re: atherectomy, duration of support.

Phase: Phase 3
Study type: Interventional
Enrollment: 452
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

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 studied

Coronary Artery Disease

Browse trials for

Coronary Artery Disease 5,598

Keywords

Patient undergoing scheduled PCI

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 452 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Abiomed Inc. is the lead sponsor of 33 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

ST elevation M.I.
Pre procedure cardiac arrest within 24 hours.
Subject in cardiogenic shock

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 452 participants (actual)

Study arms

Experimental
IMPELLA LP 2.5
Device: IMPLELLA LP 2.5
Active comparator
IABP Intra-aortic balloon pump
Device: IABP Intra-aortic balloon pump

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

50 sites

University of Alabama
Birmingham, Alabama 35294, United States
Mercy Gilbert Medical Center
Gilbert, Arizona 85297, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona 85006, United States
California Cardiovascular/Washington Hospital
Fremont, California 94538, United States
Foundation for Cardiovascular Medicine
La Jolla, California 92037, United States
University of Southern California
Los Angeles, California 90033, United States
University of Miami
Miami, Florida 33136, United States
Munroe Regional Medical Center
Ocala, Florida 34471, United States
Emory Crawford Long Hospital
Atlanta, Georgia 30308, United States
Medical College Of Georgia
Augusta, Georgia 30912, United States
University of Chicago Medical Center
Chicago, Illinois 60637, United States
Loyola University Medical Center
Maywood, Illinois 60153, United States
Washington Adventist Hospital
Takoma Park, Maryland 20912, United States
Massach General Hospital
Boston, Massachusetts 02114, United States
Brigham & Womens
Boston, Massachusetts 02115, United States
St. Elizabeths Medical Center
Boston, Massachusetts 02135, United States
Oakwood Hospital Wayne State University
Dearborn, Michigan 48124, United States
Henry Ford Medical
Detroit, Michigan 35294, United States
Harper Hospital
Detroit, Michigan 48201, United States
St. John Hospital and Medical Center
Detroit, Michigan 48236, United States
Northern Michigan
Petoskey, Michigan 49770, United States
William Beaumont
Royal Oak, Michigan 48073, United States
Providence Hospital and Medical Centers
Southfield, Michigan 48075, United States
St. Louis University
St. Louis, Missouri 63110, United States
Bryan LGH Heart Institute
Lincoln, Nebraska 68506, United States
Morristown Memorial
Morristown, New Jersey 07962, United States
Columbia Presbyterian Hospital
New York,, New York 10032, United States
Mt. Sinai School of Medicine
New York, New York 10029-6574, United States
Strong Memorial Hospital
Rochester, New York 14642, United States
Carolinas Medical Center
Charlotte, North Carolina 28203, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Cardiovascular Research of Forsythe Medical
Winston-Salem, North Carolina 27103, United States
University of Cincinnati
Cincinnati, Ohio 45267, United States
Riverside Methodist
Columbus, Ohio 43214, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213, United States
Robert Packer Hospital
Sayre, Pennsylvania 18840, United States
Pinnacle Health
Wormleysburg, Pennsylvania 17043, United States
York Hospital
York, Pennsylvania 17403, United States
Veteran's Affairs Medical Center Dallas
Dallas, Texas 75216, United States
Methodist Hospital
Houston, Texas 77030, United States
University of Texas Medical School at Houston
Houston, Texas 77030, United States
Intermountain Medical Center
Murray, Utah 84157, United States
St. Joseph's Hospital
Bellingham, Washington 98225, United States
University of Washington
Seattle, Washington 98198, United States
Royal Alexandra Hospital
Edmonton, Alberta T5H3V9, Canada
University of Alberta Hospital
Edmonton, Alberta T6G2B7, Canada
Ottawa Heart Institute
Ottawa, Ontario K1Y4W7, Canada
Toronto General Hospital
Toronto, Ontario M5G1Z5, Canada
Royal Victoria Hospital at McGill
Montreal, Quebec H3A1A1, Canada
Academic Medical Center
Amsterdam, Netherlands

References and documents

Publications

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. PubMed 26542494 ↗
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. PubMed 26385039 ↗
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. PubMed 25689546 ↗
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. PubMed 24655695 ↗
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. PubMed 24527505 ↗
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. PubMed 22935569 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00562016
Lead sponsor: Abiomed Inc.
First posted: Nov 21, 2007
Start date: Oct 2007
Primary completion: Apr 2011 (estimated)
Completion: Sep 2011 (estimated)
Last update: Mar 21, 2011

Study contacts

William O'Neill

principal investigator · Not affilicated with Abiomed

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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