Shockwave Medical has initiated the DISRUPT CAD IV study of its intravascular lithotripsy (IVL) system with the aim of using data from the study to support regulatory device approval in Japan. The system is used in the management of heavily calcified coronary arteries.
A press release from the company reports that principal investigator Shigeru Saito (Shonan Kamakura General Hospital, Kamakura, Japan) has enrolled the first patient. DISRUPT CAD IV is a prospective, multicentre, single-arm study to demonstrate the safety and effectiveness of the Shockwave coronary IVL system with the Shockwave C2 IVL catheter in the treatment of de novo, calcified, stenotic, coronary arteries prior to stenting. The study is expected to enrol up to 64 patients at eight sites in Japan.
Similar to the DISRUPT CAD III study protocol, CAD IV will assess the absence of major adverse cardiac events within 30 days of the index procedure as the primary safety endpoint. The primary effectiveness endpoint is procedural success, defined as stent delivery with a residual stenosis <50%, and without in-hospital MACE. Study enrolment is expected to be completed by June 2020, from which enrolled patients will be followed for two years.
Saito comments: “We are honoured to initiate the clinical investigation of coronary IVL in Japan to evaluate calcium modification. From the European results and our initial experience with the technology, IVL therapy has the potential to change the way we treat calcified lesions for the future benefit of patients.”
Doug Godshall, president and CEO of Shockwave Medical, says: “Based on the interest, feedback and rapid adoption in other Asia Pacific countries where we have introduced coronary IVL, we are excited for the prospect of providing Japanese physicians with access to this therapy for the first time. Japan holds tremendous potential for IVL, and we look forward to completing the study and working with the regulators so that Japanese patients and their providers will be able to access IVL therapy as soon as possible.”
Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and other select countries. However, their use in Japan is limited to investigational use within the DISRUPT CAD IV study. In the USA they are limited to investigational use within the DISRUPT CAD III study.