The PROTECT-EU Study

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.

Eligibility 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:

* 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)
* 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.

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).
* 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
* 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.