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

Exclusion Criteria

• •1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
• •2. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
• •3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
• •4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
• •5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
• •6. 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 greater than 1 times the local laboratory's upper limit of normal
• •7. New York Heart Association (NYHA) class III or IV heart failure
• •8. Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73m2 (using CKD-EPI formula)
• •9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
• •10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months
• •11. Untreated pre-procedural hemoglobin \<10 g/dL or intention to refuse blood transfusions if one should become necessary
• •12. 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)
• •13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other related blood disorders
• •14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• •15. Subjects with clinical evidence of cardiogenic shock
• •16. Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
• •17. Subjects with a life expectancy of less than 1 year
• •18. 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
• •19. 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
• •20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
• •21. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
• •22. Unprotected left main diameter stenosis \>30%
• •23. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
• •24. Evidence of aneurysm in target vessel within 10 mm of the target lesion
• •25. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
• •26. Previous stent within 5 mm of the target lesion regardless of the timing of its implantation
• •27. Angiographic evidence of a dissection or perforation in the target vessel at baseline or after guidewire passage