The PROTECT-EU Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- Death [at 90 days]
Composite endpoint of all-cause death
- Cerebrovascular accident [at 90 days]
Cerebrovascular accident at 90 days
- infarction [at 90 days]
myocardial infarction
- revascularization [at 90 days]
repeat revascularization
Secondary Outcome Measures
- hospitalization for cardiovascular cause [at 90 days]
cardiovascular disease
- hospitalization for cardiovascular cause [at 1 year]
cardiovascular disease
- cerebrovascular events [at 90 days]
cerebrovascular events (all, stroke and TIA)
- cerebrovascular events [at 1 year]
cerebrovascular events (all, stroke and TIA)
- QoL: KCCQ [at 90 days]
KCCQ (Kansas City Cardiomyopathy Questionnaire)
- QoL: EQ-5D [at 90 days]
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.
- QoL: KCCQ [at 1 year]
KCCQ (Kansas City Cardiomyopathy Questionnaire)
- QoL: EQ-5D [at 1 year]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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:
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Unprotected left main distal disease involving bifurcation or trifurcation or left main equivalent
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Diffuse degenerated (>5 mm) saphenous vein grafts involving the proximal or distal anastomosis or in-stent restenosis
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LAD (left anterior descending) long lesions (>48 mm) involving both septal and diagonal branches requiring multiple and overlapping stents
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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
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Complex CTO (chronic total occlusion) (J-CTO score 3) or CTO in patients with MVD (Coronary Microvascular Disease)
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MV-PCI (Multivessel Percutaneous Coronary Intervention) in patient with a Syntax score>32 undergoing planned complete revascularization (see protocol definition of severe stenosis)
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(only in ACS Acute Coronary Syndrome patients) Giant thrombus (length ≥3x vessel diameter) in the context of MVD or Syntax score >32.
Exclusion Criteria:
- 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).
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Cardiac arrest
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Patients admitted for ACS due to ST-elevation MI (ST Elevation Myocardial Infarction)
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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
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Age < 18 or > 80 years old
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Inability to understand and sign informed consent
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Serious known concomitant disease with a life expectancy of less than one year
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Prior thrombolytic therapy during the index event (within 72 h of presentation)
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Severe renal impairment Renal insufficiency (GFR Glomerular Filtration Rate <30 ml/min)
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Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban) at the time of PCI
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Suspected or known pregnancy
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Suspected active infection
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Current participation in an investigational study using a drug or device.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Giuseppe Tarantini | Padua | Italy |
Sponsors and Collaborators
- Fondazione GISE Onlus
- Abiomed Inc.
- University of Padova
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GISE_PROTECTEU