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

Eligibility Criteria

• * 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
• 1. The target lesion is a de novo native coronary lesion
• 2. 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
• 3. The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site
• 4. 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
• 1. Presence of large thrombus in the target vessel
• 2. Inability to pass coronary guidewire across the lesion
• 3. 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
• 4. The target lesion is within a coronary artery bypass graft
• 5. The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
• 6. Coronary artery disease that requires surgical revascularization
• 7. Angiographic or imaging evidence of dissection in the target vessel prior to randomization
• 8. Investigator feels there is not equipoise regarding the treatment strategy