Overview

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.

Eligibility

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.