Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)
The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
• 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