Heart FailureNCT02831881
Protected PCI Study
An observational study of Heart Failure, run by Abiomed Inc. at 1 site in United States.
Trial summary
A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- How many people
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2020
- Phase
- Observational
- 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
Study population: The study population will consist of high risk subjects indicated for nonemergent percutaneous treatment after heart team evaluation including a cardiac surgeon of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft.
Who may be able to join
- Signed Informed Consent
- Subject is indicated for a NON emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft per the judgement of a heart team including a surgeon
- Age eligible (18 ≤ Age ≤ 90)
- Subject presents with:
- Ejection Fraction≤ 35% AND at least one of the following criteria:
- Intervention on the last patent coronary conduit, or Intervention on an unprotected left main coronary artery Or
- Ejection Fraction ≤ 30% and intervention in patient presenting with triple vessel disease. *three-vessel or triple vessel disease is defined as at least one significant stenosis* in all three major epicardial territories: Left Anterior Descending (LAD) Artery and/or side branch, left circumflex (LCX) artery and/or side branch, Right Coronary Artery (RCA) and or side branch. *Significant stenosis is defined as at least 50% diameter stenosis by visual estimate or any total occlusion. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCX qualifies as three-vessel disease.
Who cannot join
- 1. ST Myocardial Infarction within 24 hours or CK-MB that have not normalized
- 2. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR
- 3. Subject is inotrope dependent or in cardiogenic shock defined as: Hypotension (systolic BP < 90 mmHg for > 30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR a urine output of < 30 ml/hour)
- 4. Mural thrombus in the left ventricle
- 5. Patient scheduled for revascularization of a total chronic occlusion (CTO) or transcatheter aortic valve replacement within 1 year of index procedure.
- 6. The presence of a mechanical aortic valve or heart constrictive device
Show all 17Show fewer
- 7. Documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less.
- 8. Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2)
- 9. Severe peripheral arterial obstructive disease that would preclude the IMPELLA System device placement
- 10. Abnormalities of the aorta that would preclude surgery, including aneurysms and extreme tortuosity or calcifications
- 11. Subject with renal failure (creatinine ≥ 4mg/dL or on dialysis)
- 12. Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥ 2
- 13. Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.0.)
- 14. History of recent (within 1 month) stroke or TIA
- 15. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors(clopidogrel and ticlid) or contrast media
- 16. Subject with documented heparin induced thrombocytopenia
- 17. Participation in the active follow-up phase of another clinical study of an investigational drug or device
Trial locations and contacts
1 site in 1 country.
Ioana Ghiu, MD contact
United States1 site, 1 recruiting
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
About this study
Official title: PROTECTED PCI STUDY: A Prospective Clinical Trial For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System
A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients.
Read the detailed description
The objective of the study is to assess the safety and efficacy of the IMPELLA® 2.5 System in subjects undergoing non-emergent high-risk percutaneous coronary intervention (PCI) post market approval. The primary endpoint will be a composite clinical endpoint of major adverse events through 90 days following the PCI procedure. The outcome will be compared to the pre specified performance goal of 53%.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite rate of the following intra-procedural and post-procedural major adverse events (MAE) at 90 days post index procedure.
The primary endpoint is defined as a composite rate of the major adverse events at 90 days post index procedure
Measured: 90 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research
- Responsible party
- Sponsor
- Investigators
- William O'Neill, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831881
- Sponsor's protocol ID
- PROTECT III
- Status last verified
- Jul 2016
- First submitted
- 1 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECTED PCI STUDY: A Prospective Clinical Trial For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System
- ClinicalTrials.gov ID
- NCT02831881
- Acronym / sponsor ID
- PROTECT III
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baim Institute for Clinical Research
- Study start
- Nov 2015
- Primary completion
- Nov 2020 (estimated)
- First posted
- 13 Jul 2016 (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.
A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients.
Detailed description
The objective of the study is to assess the safety and efficacy of the IMPELLA® 2.5 System in subjects undergoing non-emergent high-risk percutaneous coronary intervention (PCI) post market approval. The primary endpoint will be a composite clinical endpoint of major adverse events through 90 days following the PCI procedure. The outcome will be compared to the pre specified performance goal of 53%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of high risk subjects indicated for nonemergent percutaneous treatment after heart team evaluation including a cardiac surgeon of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft.
Key inclusion criteria (7 listed)
- Signed Informed Consent
- Subject is indicated for a NON emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft per the judgement of a heart team including a surgeon
- Age eligible (18 ≤ Age ≤ 90)
- Subject presents with:
- Intervention on the last patent coronary conduit, or Intervention on an unprotected left main coronary artery Or
Key exclusion criteria (17 listed)
- 1. ST Myocardial Infarction within 24 hours or CK-MB that have not normalized
- 2. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR
- 3. Subject is inotrope dependent or in cardiogenic shock defined as: Hypotension (systolic BP < 90 mmHg for > 30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR a urine output of < 30 ml/hour)
- 4. Mural thrombus in the left ventricle
- 5. Patient scheduled for revascularization of a total chronic occlusion (CTO) or transcatheter aortic valve replacement within 1 year of index procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A composite rate of the following intra-procedural and post-procedural major adverse events (MAE) at 90 days post index procedure.
Time frame: 90 days post index procedure
The primary endpoint is defined as a composite rate of the major adverse events at 90 days post index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Ioana Ghiu, MD contact
William O'Neill, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abiomed Inc. at 1 site in United States.
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 17 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: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioana Ghiu, MD (ighiu@abiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite rate of the following intra-procedural and post-procedural major adverse events (MAE) at 90 days post index procedure. (time frame: 90 days post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2016.