DISRUPT CAD IV Study Begins in Japan for Shockwave Coronary Intravascular Lithotripsy System

November 7, 2019—Shockwave Medical, Inc. announced the initiation of the DISRUPT CAD IV study of intravascular lithotripsy (IVL) in heavily calcified coronary arteries. The study is intended to support regulatory device approval in Japan.

DISRUPT CAD IV is a prospective, multicenter, 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 before stenting. The study is expected to enroll up to 64 patients at eight sites in Japan.

The first patient in the study was enrolled by Principal Investigator Shigeru Saito, MD, Director of Cardiology and Catheterization Laboratories and Vice President of Shonan Kamakura General Hospital in Kamakura, Japan.

In the company’s press release, Dr. Saito commented, “We are honored 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.”

Similar to the DISRUPT CAD III United States study protocol, the CAD IV study will assess the absence of major adverse cardiac events (MACE) 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 enrollment is expected to be completed by June 2020, from which enrolled patients will be followed for 2 years.

Shockwave’s coronary IVL therapy is designed to treat calcified artery blockages with sonic pressure waves historically used to treat patients with kidney stones. The technology seeks to minimize trauma within the artery by delivering pulsatile sonic pressure waves locally to fracture both intimal and medial calcium in the artery wall but pass through surrounding soft vascular tissue in a safe manner.

The Shockwave C2 coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and other select countries; in Japan they are limited to investigational use within the DISRUPT CAD IV study, and in the United States they are limited to investigational use within the DISRUPT CAD III study, advised the company.