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

1. Subject is ≥18 years of age

2. Subjects with native coronary artery disease (including stable or unstable anginaand silent ischemia) suitable for PCI

3. 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 12hours prior to the procedure (note: both must be normal)

4. For subjects with stable ischemic heart disease, biomarkers may be drawn prior tothe procedure or at the time of the procedure from the side port of the sheath

5. If drawn prior to the procedure, biomarkers (CK-MB and troponin) must be lessthan or equal to the upper limit of the laboratory normal within 12 hours ofthe procedure (note: both must be normal)

6. If drawn at the time of the procedure from the side port of the sheath prior toany intervention, biomarker results do not need to be analyzed prior toenrollment

7. Left ventricular ejection fraction >25% within 6 months (note: in the case ofmultiple assessments of LVEF, the measurement closest to enrollment will be used forthis criterion; may be assessed at time of index procedure)

8. Subject or legally authorized representative, signs a written Informed Consent formto participate in the study, prior to any study-mandated procedures

9. Non-target lesions requiring PCI may be treated either

10. >30 days prior to the study procedure if the procedure was unsuccessful orcomplicated; or

11. >24 hours prior to the study procedure if the procedure was successful anduncomplicated (defined as a final lesion angiographic diameter stenosis <30%and TIMI 3 flow (visually assessed) for all non-target lesions and vesselswithout perforation, cardiac arrest or need for defibrillation or cardioversionor hypotension/heart failure requiring mechanical or intravenous hemodynamicsupport or intubation, and with no post-procedure biomarker elevation >normal;or

12. >30 days after the study procedure Angiographic Inclusion Criteria

13. The target lesion must be a de novo coronary lesion that has not been previouslytreated with any interventional procedure

14. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or oftheir branches) with

15. Stenosis of ≥70% and <100%, or

16. Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia viapositive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 orIVUS or OCT minimum lumen area ≤4.0 mm2

17. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

18. The lesion length must not exceed 40 mm

19. The target vessel must have TIMI flow 3 at baseline (visually assessed; may beassessed after pre- dilatation)

20. Evidence of calcification at the lesion site by, a) angiography, with fluoroscopicradio-opacities noted without cardiac motion prior to contrast injection involvingboth sides of the arterial wall in at least one location and total length of calciumof at least 15 mm and extending partially into the target lesion, OR by b) IVUS orOCT, with presence of ≥270 degrees of calcium on at least 1 cross section

21. Ability to pass a 0.014" guide wire across the lesion

Exclusion Criteria: Subjects who meet any of the following exclusion criteria may not be enrolled in the study:

General 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 investigationalagent (pharmaceutical, biologic, or medical device) that has not reached the primaryendpoint

3. Subject is pregnant or nursing (a negative pregnancy test is required for women ofchild-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 adequatelypre-medicated

6. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to indexprocedure, defined as a clinical syndrome consistent with an acute coronary syndromewith 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 (usingCKD-EPI formula)

9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any priorintracranial 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 bloodtransfusions if one should become necessary

12. Coagulopathy, including but not limited to platelet count <100,000 or InternationalNormalized ratio (INR) > 1.7 (INR is only required in subjects who have takenwarfarin 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 witheither 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 indexprocedure

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 investigationaldevice other than lithotripsy Angiographic Exclusion Criteria

22. Unprotected left main diameter stenosis >30%

23. Definite or possible thrombus (by angiography or intravascular imaging) in thetarget 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 goingthrough a saphenous vein or arterial bypass graft

26. Previous stent within 5 mm of the target lesion regardless of the timing of itsimplantation

27. Angiographic evidence of a dissection or perforation in the target vessel atbaseline or after guidewire passage