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

This study has been terminated.

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

Sponsor:

Information provided by:

Abiomed Inc.

ClinicalTrials.gov Identifier:

NCT00562016

First received: November 19, 2007

Last updated: March 18, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 19, 2007

Last Updated Date

March 18, 2011

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. [ Time Frame: 30 days +/- 10 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Composite rate of intra porcedural and post procedural major events. Death, MI,Stroke,TIA, TVR, CABG, Acute renal failure, severe hypotension, CPR Vent Arrythmia requiring, failure angiographic success. [ Time Frame: 30 days ]

Change History

Complete list of historical versions of study NCT00562016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. [ Time Frame: In hospital events ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Protect II, A Prospective, Multicenter Randomized Controlled Trial

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavík 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

452

Estimated Completion Date

September 2011

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00562016

Other Study ID Numbers ^ICMJE

7182007

Has Data Monitoring Committee

Yes

Responsible Party

Carol Pekar/Director of Clinical and Regulatory Affairs, Abiomed Inc

Study Sponsor ^ICMJE

Abiomed Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William O'Neill

Not affilicated with Abiomed

Information Provided By

Abiomed Inc.

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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