Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)

Inclusion criteria

• . Subjects aged between 18 and 85.
• . Subjects who can undergo percutaneous coronary intervention (PCI).
• . Subjects with asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction.
• . Left Ventricular Ejection Fraction (LVEF) ≥30% as measured by echocardiography for subjects within 6 months before enrollment. (In case of multiple LVEF results, the data closest to the baseline procedure was taken.)
• . Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
• . There is only one target lesion that needs to be treated.
• . The target lesion must be located in a de novo native coronary artery with a reference vessel diameter (RVD) ≥2.00 mm to ≤4.00 mm as visually measured.
• . The target lesion angiography shows a stenosis rate ranging from ≥70% (visually measured) or ≥50% to \<70% with symptoms of ischemia.

Exclusion criteria