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

Prior treatment

• Patient has a known allergy to contrast which cannot be adequately pre-treated
• Angiographic or imaging evidence of dissection in the target vessel prior to randomization

Other illness

• Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
• Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
  • Angiographic Exclusion Criteria
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• Coronary artery disease that requires surgical revascularization

Lab values

• Known LVEF \< 25%
• Patient is unable to tolerate dual anti-platelet therapy
• The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification

Other

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• Patient is pregnant
• Patient is actively participating in another clinical trial
• Ongoing Non-STEMI with rising biomarkers
• Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
• Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
• Patient presents with STEMI
• Presence of large thrombus in the target vessel
• Inability to pass coronary guidewire across the lesion
• 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
• The target lesion is within a coronary artery bypass graft
• Investigator feels there is not equipoise regarding the treatment strategy

• 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
  • The target lesion is a de novo native coronary lesion
  • The target vessel is a native coronary artery with either:
  • A stenosis \> 70%; or,
  • 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
  • The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site
  • The target lesion has evidence of significant calcium at the lesion site defined either as,
  • The presence of radiopacities involving both sides of the arterial wall \> 5mm and involving the target lesion on angiography
  • the presence of \> 270o arc of superficial calcium on intravascular imaging with a length \> 5mm or the presence of 360o arc of superficial calcium