Patients Undergoing High Risk PCI.Phase 2PROTECT INCT00534859
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
A Phase 2 study testing High Risk PCI in people with Patients Undergoing High Risk PCI., run by Abiomed Inc. at 10 sites in 2 countries.
Trial summary
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Patients Undergoing High Risk PCI.
- What is being tested?
- High Risk PCI
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2006to Mar 2011
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
- EF <35%
Who cannot join
- ST Myocardial Infarction
- Cardiac Arrest
- Cardiogenic Shock
- Thrombus Left Ventricle
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Mass General Hospital
Boston, Massachusetts, 02114
Brigham & Womens
Boston, Massachusetts, 02115
Texas Heart
Houston, Texas, 777030
Scripps
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mt. Sinai School of Medicine
New York, New York, 10029-6574
Columbia Presbyterian Hospital
New York, New York, 10032
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
William Beaumont
Royal Oak, Michigan, 48073
About this study
Official title: PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.
- Conditions
- Patients Undergoing High Risk PCI.
- Being tested
- High Risk PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Risk PCIDevice
High Risk Percutaneous Coronary Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE Events at 30 days or discharge, whichever is longer
Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.
Measured: 30 days or discharge
Freedom from Hemodynamic compromise during PCI procedure
Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required
Measured: During procedure
Secondary outcomes (3)
Other intra-procedural and peri-procedural adverse events
Measured: During treatment and out to 90 days
Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion
Freedom from the following procedural-related events:
- Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion
Measured: During procedure
Angiographic Success
Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty.
Measured: Post-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startAug 2006
- Primary completionJun 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing High Risk PCI.Studies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William O'Neill, M.D., Principal investigator, Not affiliated with Abiomed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534859
- Sponsor's protocol ID
- G050017
- Acronym
- PROTECT I
- Status last verified
- Mar 2011
- First submitted
- 24 Sep 2007
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005.
PubMed 19463408
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
- ClinicalTrials.gov ID
- NCT00534859
- Acronym / sponsor ID
- PROTECT I / G050017
- Conditions
- Patients Undergoing High Risk PCI.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
- EF <35%
Key exclusion criteria (4 listed)
- ST Myocardial Infarction
- Cardiac Arrest
- Cardiogenic Shock
- Thrombus Left Ventricle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Risk PCIHigh Risk Percutaneous Coronary Intervention | Device | – |
Primary outcome
MACCE Events at 30 days or discharge, whichever is longer
Time frame: 30 days or discharge
Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.
Freedom from Hemodynamic compromise during PCI procedure
Time frame: During procedure
Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required
3 secondary outcomes
Other intra-procedural and peri-procedural adverse events
Time frame: During treatment and out to 90 days
Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion
Time frame: During procedure
Angiographic Success
Time frame: Post-PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2011.
- Derived from this study: PubMed 19463408Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005.
Related trials for Patients Undergoing High Risk PCI.
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Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
RecruitingPhase 4
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
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Active, not recruiting
Impella ECP Early Feasibility Study
High-risk Percutaneous Coronary Intervention
Not yet recruitingPhase 3
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors With Statin for ACS Patients
Acute Coronary Syndromes
Active, not recruiting
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
High-risk PCI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William O'Neill, M.D. principal investigator
Not affiliated with Abiomed
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Risk PCI in people with Patients Undergoing High Risk PCI., run by Abiomed Inc. at 10 sites in 2 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 3 inclusion and 4 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: finished, 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 10 sites in United States, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MACCE Events at 30 days or discharge, whichever is longer (time frame: 30 days or discharge). The study lists 2 primary outcomes in all. 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 NCT00534859, which also lists 1 linked publication.
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.