Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial

Inclusion Criteria:

• 1. Subject is > 21 years old 2. Subject with an indication for PCI for the treatmentof a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidenceof down-trending biomarkers 3. Subject is willing and able to provide informedwritten consent Angiographic Inclusion Criteria

1. The target lesion is a de novo native coronary lesion

2. The target vessel is a native coronary artery with either:

3. A stenosis > 70%; or,

4. A stenosis > 50% and <70% with evidence of ischemia via either positivestress test, FFR value < 0.80 or RFR/iFR/DFR value < 0.89

5. The reference diameter of the target vessel is > 2.5mm and < 4.0 mm at thelesion site

6. The target lesion has evidence of significant calcium at the lesion sitedefined either as,

7. The presence of radiopacities involving both sides of the arterial wall > 5mm and involving the target lesion on angiography

8. the presence of > 270o arc of superficial calcium on intravascular imagingwith a length > 5mm or the presence of 360o arc of superficial calcium

Exclusion Criteria:

1. Patient is pregnant

2. Patient is actively participating in another clinical trial

3. Known LVEF < 25%

4. Ongoing Non-STEMI with rising biomarkers

5. Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamicsupport

6. Planned use in the randomized lesion of a bare metal stent or non-stenttreatment only

7. Patient has a known allergy to contrast which cannot be adequately pre-treated

8. Patient has a history of bleeding or coagulopathy and is unable to receiveblood transfusion if needed

9. Patient presents with STEMI

10. Patient is unable to tolerate dual anti-platelet therapy

11. Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30daysAngiographic Exclusion Criteria

12. Presence of large thrombus in the target vessel

13. Inability to pass coronary guidewire across the lesion

14. The target vessel has excessive tortuosity (Defined as presence of 2+ bends > 90o or 3+ bends > 75o) or other anatomic considerations that precludesintravascular imaging

15. The target lesion is within a coronary artery bypass graft

16. The target lesion involves a bifurcation lesion in which either a 2-stentstrategy is planned or both branches are planned for calcium modification

17. Coronary artery disease that requires surgical revascularization

18. Angiographic or imaging evidence of dissection in the target vessel prior torandomization

19. Investigator feels there is not equipoise regarding the treatment strategy