ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

Prior treatment

• Inability to tolerate dual antiplatelet therapy for 6 months or longer

Lab values

• Ejection fraction less than 25%
• Severe renal Impairment; Serum Creatinine \> 220 μmol or currently undergoing hemodialysis

Other

• Lesion located in Left Main (LM) coronary artery
• Calcifications located mostly \> 0.5 mm from the vessel lumen.
• Severe lesion tortuosity where OCT is judged impossible to cross.
• Inability to obtain inform consent or deemed poorly compliant by the investigator
• Presence of permanent pacemaker
• Angiographic evidence of thrombus in the target vessel
• Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX)
• Target lesion is a chronic total occlusion (CTO)
• Presence of aneurysm within 10mm proximal or distal to the target lesion

• Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where heart enzymes are decreasing
  • Angiographic criteria:
• Native de novo coronary lesions
• Vessel diameter between 2.5mm - 4.0mm
• Lesion Length: ≤40mm
• Severe Calcification:
  • Calcification visible on the upper and the lower sides of the vessel wall in at least two angiographic projections that differ ≥ 60° from each other
  • Presence of severe calcified protruding noduli
• No flow disturbances at baseline (Thrombolysis in Myocardial Infarction \[TIMI\] 3 flow at baseline)
• Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia
  • OCT Criteria:
• Total calcium arc \> 180° or
• Presence of a protruding calcified noduli