Disrupt CAD IV With the Shockwave Coronary IVL System

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 patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn both must be normal)
• For patients 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 (troponin or CK- MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the index procedure (note: if both labs are drawn, both must be normal)
• If biomarkers are 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 criteria; 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
• Lesions in non-target vessels 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 2.5 mg/dL, or chronic dialysis
• History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
• Active peptic ulcer or upper gastrointestinal (GI) b≥leeding within 6 months
• Untreated pre-procedural hemoglobin 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 disorders
• Uncontrolled diabetes defined as a HbA1c ≥10%
• Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
• 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 (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure
• Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures 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
• Unprotected left main diameter stenosis >30%
• Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
• 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 an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left