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Coronary Artery DiseasePhase 3PROTECT IINCT00562016

Protect II, A Prospective, Multicenter Randomized Controlled Trial

A Phase 3 study testing IMPLELLA LP 2.5 and IABP Intra-aortic balloon pump in people with Coronary Artery Disease, run by Abiomed Inc. at 50 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
IMPLELLA LP 2.5 and IABP Intra-aortic balloon pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
50 sitesin 3 countries
Study dates
Oct 2007to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

50 sites in 3 countries.

50 sites in 3 countries

United States44 sites

  • Emory Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Medical College Of Georgia

    Augusta, Georgia, 30912

  • St. Joseph's Hospital

    Bellingham, Washington, 98225

  • University of Alabama

    Birmingham, Alabama, 35294

  • Massach General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Womens

    Boston, Massachusetts, 02115

  • St. Elizabeths Medical Center

    Boston, Massachusetts, 02135

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Riverside Methodist

    Columbus, Ohio, 43214

  • Veteran's Affairs Medical Center Dallas

    Dallas, Texas, 75216

  • Oakwood Hospital Wayne State University

    Dearborn, Michigan, 48124

  • Henry Ford Medical

    Detroit, Michigan, 35294

  • Harper Hospital

    Detroit, Michigan, 48201

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • California Cardiovascular/Washington Hospital

    Fremont, California, 94538

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Methodist Hospital

    Houston, Texas, 77030

  • University of Texas Medical School at Houston

    Houston, Texas, 77030

  • Foundation for Cardiovascular Medicine

    La Jolla, California, 92037

  • Bryan LGH Heart Institute

    Lincoln, Nebraska, 68506

  • University of Southern California

    Los Angeles, California, 90033

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Morristown Memorial

    Morristown, New Jersey, 07962

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Mt. Sinai School of Medicine

    New York, New York, 10029-6574

  • Columbia Presbyterian Hospital

    New York, New York, 10032

  • Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Northern Michigan

    Petoskey, Michigan, 49770

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Strong Memorial Hospital

    Rochester, New York, 14642

  • William Beaumont

    Royal Oak, Michigan, 48073

  • Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • University of Washington

    Seattle, Washington, 98198

  • Providence Hospital and Medical Centers

    Southfield, Michigan, 48075

  • St. Louis University

    St Louis, Missouri, 63110

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Cardiovascular Research of Forsythe Medical

    Winston-Salem, North Carolina, 27103

  • Pinnacle Health

    Wormleysburg, Pennsylvania, 17043

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Canada5 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H3V9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2B7

  • Royal Victoria Hospital at McGill

    Montreal, Quebec, H3A1A1

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

  • Toronto General Hospital

    Toronto, Ontario, M5G1Z5

Other trials in Canada

Netherlands1 site

  • Academic Medical Center

    Amsterdam, Netherlands

Other trials in Netherlands

About this study

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

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.

Being tested
IMPLELLA LP 2.5, IABP Intra-aortic balloon pump
Keywords
Patient undergoing scheduled PCI
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMPLELLA LP 2.5Device

    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 pumpDevice

    IABP uses counterpulsation to provide 0.2L/min coronary flow

Study groups in NCT00562016
Study groupRoleWhat they receive
IMPELLA LP 2.5ExperimentalNot described
Receives: Device: IMPLELLA LP 2.5
IABP Intra-aortic balloon pumpActive comparatorNot described
Receives: Device: IABP Intra-aortic balloon pump

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days +/- 10 days

Secondary outcomes (1)

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

    Measured: In hospital events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionApr 2011 (estimated)
  4. Study completionSep 2011 (estimated)

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00562016
Sponsor's protocol ID
7182007
Acronym
PROTECT II
Status last verified
Mar 2011
First submitted
19 Nov 2007
Last updated
21 Mar 2011
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMPLELLA LP 2.5 and IABP Intra-aortic balloon pump in people with Coronary Artery Disease, run by Abiomed Inc. at 50 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Futility on primary endpoint.Study confounded by statistically significant differences between the two arms re: atherectomy, duration of support.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. (time frame: 30 days +/- 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00562016, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2011.

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PROTECT II Clinical Trial NCT00562016 | AzTrials