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.
⁃ 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.