High-risk PCINCT05466552
The PROTECT-EU Study
An observational study of High-risk PCI, run by Fondazione GISE Onlus at 1 site in Italy.
Trial summary
The PROTECT-EU Registry is a prospective, non-randomized, multi-national registry to evaluate 90 days outcomes in high risk-PCI (Percutaneous coronary intervention) patients treated with a preventive strategy with Impella CP® System. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High-risk PCI
- What is being tested?
- PCI procedure
- Type of treatment
- Surgery or procedure
- How many people
- 859 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2022to 1 Jun 2024
- How long will I take part?
- 1 Year
- 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 80 years
- All sexes
- Adult, Older adult
Study population: High-risk PCI population defined with clinical and angiographic criteria. Impella will be started after coronary angiography and before PCI and will be discontinued before discharge from the catheterization laboratory if the patient is deemed hemodynamically stable. All subjects will have 1-year follow-up. The primary endpoint will be assessed at 90 days follow-up.
Who may be able to join
- Patients with non-emergent chronic or acute coronary syndromes (the former refused from surgical revascularization) with reduced LVEF (left ventricular ejection fraction)(<=40%) and indication for high-risk PCI AND
- Intended high-risk PCI defined as having at least one of the following criteria:
- Unprotected left main distal disease involving bifurcation or trifurcation or left main equivalent
- Diffuse degenerated (>5 mm) saphenous vein grafts involving the proximal or distal anastomosis or in-stent restenosis
- LAD (left anterior descending) long lesions (>48 mm) involving both septal and diagonal branches requiring multiple and overlapping stents
- Diffuse and severely calcified lesions (see protocol definition) with need for debulking devices (directional, rotational, orbital, and laser)
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- Last patent conduit
- Complex CTO (chronic total occlusion) (J-CTO score 3) or CTO in patients with MVD (Coronary Microvascular Disease)
- MV-PCI (Multivessel Percutaneous Coronary Intervention) in patient with a Syntax score>32 undergoing planned complete revascularization (see protocol definition of severe stenosis)
- (only in ACS Acute Coronary Syndrome patients) Giant thrombus (length ≥3x vessel diameter) in the context of MVD or Syntax score >32.
Who cannot join
- Classic CS Coronary Sinus (relative hypotension as SBP < 90 mmHg, or MAP <60 mmHg or >30 mmHg drop from baseline and drugs/device used to maintain blood pressure above these targets and/or symptoms/signs of hypoperfusion as cardiac index <2.2, lactate ≥ 2mmol/L (24).
- Cardiac arrest
- Patients admitted for ACS due to ST-elevation MI (ST Elevation Myocardial Infarction)
- Contraindication to Impella positioning: mural thrombus in the left ventricle; presence of a mechanical aortic valve; severe aortic stenosis or valvular regurgitation; severe peripheral arterial disease precluding placement of the Impella System; haematological disorder causing fragility of the blood cells or hemolysis; hypertrophic obstructive cardiomyopathy (HOCM); aneurysm or severe anomaly of the ascending aorta and/or aortic arch; significant right heart failure; presence of an atrial or ventricular sepal defect (including post-infarct VSD Ventricular Septal Defect); left ventricular rupture; cardiac tamponade; recent TIA or stroke (within 1 month); contraindication to anticoagulation
- Age < 18 or > 80 years old
- Inability to understand and sign informed consent
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- Serious known concomitant disease with a life expectancy of less than one year
- Prior thrombolytic therapy during the index event (within 72 h of presentation)
- Severe renal impairment Renal insufficiency (GFR Glomerular Filtration Rate <30 ml/min)
- Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban) at the time of PCI
- Suspected or known pregnancy
- Suspected active infection
- Current participation in an investigational study using a drug or device.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan
Vega Rusconi, MD, +390226437331 (9327 direct), rusconi.vega@hsr.it
Alaide Chieffo
About this study
Official title: A Prospective Multinational Registry on Preventive Left Ventricular Support With Impella in Anatomically High-risk PCI Treated Patients
The PROTECT-EU Registry is a prospective, non-randomized, multi-national registry to evaluate 90 days outcomes in high risk-PCI (Percutaneous coronary intervention) patients treated with a preventive strategy with Impella CP® System.
Read the detailed description
The PROTECT-EU Registry is a prospective multinational registry on preventive left ventricular support with Impella in high-risk PCI treated patients. The aim is to confirm and improve the Impella effectiveness in a selected all comers high risk population undergoing supported HR-PCI (high risk-PCI) with Impella implantation before PCI.
- Conditions
- High-risk PCI
- Being tested
- PCI procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI procedureProcedure or surgery
During the PCI procedure, use of ECMO/Impella 5.0 is allowed hemodynamic instability (bail- out).
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Composite endpoint of all-cause death
Measured: at 90 days
Cerebrovascular accident
Cerebrovascular accident at 90 days
Measured: at 90 days
infarction
myocardial infarction
Measured: at 90 days
revascularization
repeat revascularization
Measured: at 90 days
Secondary outcomes (8)
hospitalization for cardiovascular cause
cardiovascular disease
Measured: at 90 days
hospitalization for cardiovascular cause
cardiovascular disease
Measured: at 1 year
cerebrovascular events
cerebrovascular events (all, stroke and TIA)
Measured: at 90 days
cerebrovascular events
cerebrovascular events (all, stroke and TIA)
Measured: at 1 year
QoL: KCCQ
KCCQ (Kansas City Cardiomyopathy Questionnaire)
Measured: at 90 days
QoL: EQ-5D
EQ-5D: EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.
Measured: at 90 days
QoL: KCCQ
KCCQ (Kansas City Cardiomyopathy Questionnaire)
Measured: at 1 year
QoL: EQ-5D
EQ-5D: EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start18 Oct 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk PCIStudies 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
- 859 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fondazione GISE Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc., University of Padova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466552
- Sponsor's protocol ID
- GISE_PROTECTEU
- Status last verified
- Mar 2024
- First submitted
- 25 May 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multinational Registry on Preventive Left Ventricular Support With Impella in Anatomically High-risk PCI Treated Patients
- ClinicalTrials.gov ID
- NCT05466552
- Acronym / sponsor ID
- GISE_PROTECTEU
- Conditions
- High-risk PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 859 participants (estimated)
- Lead sponsor
- Fondazione GISE OnlusUniversity, hospital or other
- Collaborators
- Abiomed Inc., University of Padova
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 20 Jul 2022 (actual)
- 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 PROTECT-EU Registry is a prospective, non-randomized, multi-national registry to evaluate 90 days outcomes in high risk-PCI (Percutaneous coronary intervention) patients treated with a preventive strategy with Impella CP® System.
Detailed description
The PROTECT-EU Registry is a prospective multinational registry on preventive left ventricular support with Impella in high-risk PCI treated patients. The aim is to confirm and improve the Impella effectiveness in a selected all comers high risk population undergoing supported HR-PCI (high risk-PCI) with Impella implantation before PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- High-risk PCI population defined with clinical and angiographic criteria. Impella will be started after coronary angiography and before PCI and will be discontinued before discharge from the catheterization laboratory if the patient is deemed hemodynamically stable. All subjects will have 1-year follow-up. The primary endpoint will be assessed at 90 days follow-up.
Key inclusion criteria (10 listed)
- Patients with non-emergent chronic or acute coronary syndromes (the former refused from surgical revascularization) with reduced LVEF (left ventricular ejection fraction)(<=40%) and indication for high-risk PCI AND
- Unprotected left main distal disease involving bifurcation or trifurcation or left main equivalent
- Diffuse degenerated (>5 mm) saphenous vein grafts involving the proximal or distal anastomosis or in-stent restenosis
- LAD (left anterior descending) long lesions (>48 mm) involving both septal and diagonal branches requiring multiple and overlapping stents
- Diffuse and severely calcified lesions (see protocol definition) with need for debulking devices (directional, rotational, orbital, and laser)
Key exclusion criteria (13 listed)
- Classic CS Coronary Sinus (relative hypotension as SBP < 90 mmHg, or MAP <60 mmHg or >30 mmHg drop from baseline and drugs/device used to maintain blood pressure above these targets and/or symptoms/signs of hypoperfusion as cardiac index <2.2, lactate ≥ 2mmol/L (24).
- Cardiac arrest
- Patients admitted for ACS due to ST-elevation MI (ST Elevation Myocardial Infarction)
- Contraindication to Impella positioning: mural thrombus in the left ventricle; presence of a mechanical aortic valve; severe aortic stenosis or valvular regurgitation; severe peripheral arterial disease precluding placement of the Impella System; haematological disorder causing fragility of the blood cells or hemolysis; hypertrophic obstructive cardiomyopathy (HOCM); aneurysm or severe anomaly of the ascending aorta and/or aortic arch; significant right heart failure; presence of an atrial or ventricular sepal defect (including post-infarct VSD Ventricular Septal Defect); left ventricular rupture; cardiac tamponade; recent TIA or stroke (within 1 month); contraindication to anticoagulation
- Age < 18 or > 80 years old
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 |
|---|---|---|
| PCI procedureDuring the PCI procedure, use of ECMO/Impella 5.0 is allowed hemodynamic instability (bail- out). | Procedure or surgery | – |
Primary outcome
Death
Time frame: at 90 days
Composite endpoint of all-cause death
Cerebrovascular accident
Time frame: at 90 days
Cerebrovascular accident at 90 days
infarction
Time frame: at 90 days
myocardial infarction
revascularization
Time frame: at 90 days
repeat revascularization
8 secondary outcomes
hospitalization for cardiovascular cause
Time frame: at 90 days
hospitalization for cardiovascular cause
Time frame: at 1 year
cerebrovascular events
Time frame: at 90 days
cerebrovascular events
Time frame: at 1 year
QoL: KCCQ
Time frame: at 90 days
QoL: EQ-5D
Time frame: at 90 days
QoL: KCCQ
Time frame: at 1 year
QoL: EQ-5D
Time frame: at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 High-risk PCI, run by Fondazione GISE Onlus at 1 site in Italy.
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 10 inclusion and 13 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 4 Mar 2024. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: at 90 days). The study lists 4 primary outcomes in all. 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 4 Mar 2024.