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

Open to people ages 21 years and up

• 1. Subject is > 21 years old 2. Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers 3. Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria
  2. The target lesion is a de novo native coronary lesion
  3. The target vessel is a native coronary artery with either:
     1. A stenosis > 70%; or,
     2. A stenosis > 50% and <70% with evidence of ischemia via either positive stress test, FFR value < 0.80 or RFR/iFR/DFR value < 0.89
  4. The reference diameter of the target vessel is > 2.5mm and < 4.0 mm at the lesion site
  5. The target lesion has evidence of significant calcium at the lesion site defined either as,
     1. The presence of radiopacities involving both sides of the arterial wall > 5mm and involving the target lesion on angiography
     2. the presence of > 270o arc of superficial calcium on intravascular imaging with a length > 5mm or the presence of 360o arc of superficial calcium

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 hemodynamic support
6. Planned use in the randomized lesion of a bare metal stent or non-stent treatment 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 receive blood 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 30 days

    Angiographic 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 precludes intravascular 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-stent strategy 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 to randomization
19. Investigator feels there is not equipoise regarding the treatment strategy