Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary Stenoses: Design and rationale for the Disrupt CAD III trial

Abstract Background Coronary calcification limits optimal stent expansion and apposition and worsens safety and effectiveness outcomes of percutaneous coronary intervention (PCI). Current ablative technologies that modify calcium to optimize stent deployment are limited by guidewire bias and peri-procedural complications related to atheroembolization, coronary dissection and perforation. Intravascular lithotripsy (IVL) delivers pulsatile ultrasonic pressure waves through a fluid filled balloon into the vessel wall to modify calcium and enhance vessel compliance, reduce fibroelastic recoil, and decrease the need for high pressure balloon (barotrauma) inflations. IVL has been used in peripheral arteries as stand-alone revascularization or as an adjunct to optimize stent deployment. Study Design and Objectives. Disrupt CAD III ( clinicaltrials.gov identifier: NCT03595176 ) is a prospective, multicenter, single arm study designed to assess safety and efficacy of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with de novo calcified coronary stenoses. The primary safety endpoint is freedom from major adverse cardiovascular events (MACE: composite of cardiac death, myocardial infarction and target vessel revascularization) at 30 days compared to a pre-specified performance goal. The primary effectiveness endpoint is procedural success without in-hospital MACE. Enrollment will complete early in 2020 with clinical follow-up ongoing for 2 years. Conclusion Disrupt CAD III will evaluate the safety and effectiveness of the Shockwave coronary IVL catheter to optimize coronary stent deployment in patients with calcified coronary stenoses.