Disrupt CAD IV With the Shockwave Coronary IVL System

Exclusion Criteria

• •1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
• •2. Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
• •3. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
• •4. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
• •5. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months
• •6. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
• •7. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's upper limit of normal
• •8. New York Heart Association (NYHA) class III or IV heart failure
• •9. Renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis
• •10. History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
• •11. Active peptic ulcer or upper gastrointestinal (GI) b≥leeding within 6 months
• •12. Untreated pre-procedural hemoglobin \<10 g/dL or intention to refuse blood transfusions if one should become necessary
• •13. Coagulopathy, including but not limited to platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
• •14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders
• •15. Uncontrolled diabetes defined as a HbA1c ≥10%
• •16. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• •17. Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
• •18. Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
• •19. Subjects with a life expectancy of less than 1 year
• •20. Non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure
• •21. Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days after the index procedure
• •22. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
• •23. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
• •24. Unprotected left main diameter stenosis \>30%
• •25. Target vessel is excessively tortuous defined as the presence of two or more bends \>90º or three or more bends \>75º
• •26. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
• •27. Evidence of aneurysm in target vessel within 10 mm of the target lesion
• •28. Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
• •29. Target lesion is a bifurcation with ostial diameter stenosis ≥30%
• •30. Second lesion with \>50% stenosis in the same target vessel as the target lesion including its side branches
• •31. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
• •32. Previous stent within the target vessel implanted within the last year
• •33. Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
• •34. Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage