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.
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 Type
OBSERVATIONAL
Enrollment
859
During the PCI procedure, use of ECMO/Impella 5.0 is allowed hemodynamic instability (bail- out).
Ospedale San Raffaele
Milan, Italy
RECRUITINGDeath
Composite endpoint of all-cause death
Time frame: at 90 days
Cerebrovascular accident
Cerebrovascular accident at 90 days
Time frame: at 90 days
infarction
myocardial infarction
Time frame: at 90 days
revascularization
repeat revascularization
Time frame: at 90 days
hospitalization for cardiovascular cause
cardiovascular disease
Time frame: at 90 days
hospitalization for cardiovascular cause
cardiovascular disease
Time frame: at 1 year
cerebrovascular events
cerebrovascular events (all, stroke and TIA)
Time frame: at 90 days
cerebrovascular events
cerebrovascular events (all, stroke and TIA)
Time frame: at 1 year
QoL: KCCQ
KCCQ (Kansas City Cardiomyopathy Questionnaire)
Time frame: 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.
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Time frame: at 90 days
QoL: KCCQ
KCCQ (Kansas City Cardiomyopathy Questionnaire)
Time frame: 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.
Time frame: at 1 year