Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions

Inclusion Criteria

• •1. ≥18 years of age;
• •2. Native coronary artery disease suitable for PCI;
• •3. Patients with stable ischemic heart disease or unstable ischemic heart disease (Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-Elevation Myocardial Infarction), patients with concomitant cardiogenic shock.
• •4. Patient or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures;
• •1. The target vessel reference diameter must be ≥2.5 mm.
• •2. De novo coronary lesions or calcific in-stent restenosis or suboptimal stent expansion in a severely calcified coronary segment: Unprotected or Protected Left Main, LAD, LCfx, Ramus, RCA.
• •3. Angiographic stenosis \> 70% or stenosis \> 50% and \< 70% with FFR \< 0.80 or iFR \< 0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²;
• •4. Evidence of calcification at the lesion site: angiographic calcifications (Mintz el al Classification) are described as : None/mild, Moderate (radio-opacities noted only during cardiac cycle prior to contrast injection) severe calcification: radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.