Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

Inclusion Criteria:Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the clinical study.

General Inclusion Criteria

• Subject is ≥18 years of age
• Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
• For subjects with unstable ischemic heart disease, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours prior to the procedure (note: both must be normal)
• For subjects with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath
• If drawn prior to the procedure, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours of the procedure (note: both must be normal)
• If drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment
• Left ventricular ejection fraction >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure)
• Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
• Non-target lesions requiring PCI may be treated either
• >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
• >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis normal; or
• >30 days after the study procedure

Angiographic Inclusion Criteria

• The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
• Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with
• Stenosis of ≥70% and 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
• Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other related blood disorders
• Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• Subjects with clinical evidence of cardiogenic shock
• Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
• Subjects with a life expectancy of less than 1 year
• Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
• Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
• Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
• Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy

Angiographic Exclusion Criteria

• Unprotected left main diameter stenosis >30%
• Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
• Evidence of aneurysm in target vessel within 10 mm of the target lesion
• Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
• Previous stent within 5 mm of the target lesion regardless of the timing of its implantation
• Angiographic evidence of a dissection or perforation in the target vessel at baseline or after guidewire passage