April 6, 2020
Shockwave Completes Enrollment in DISRUPT CAD III Pivotal Trial of Coronary Intravascular Lithotripsy
April 6, 2020—Shockwave Medical, Inc. announced that the company has completed enrollment in DISRUPT CAD III, the pivotal FDA study for the use of Shockwave's intravascular lithotripsy (IVL) in heavily calcified coronary artery disease (CAD).
DISRUPT CAD III is a prospective, multicenter, single-arm, global investigational device exemption study to demonstrate the safety and effectiveness of the Shockwave Coronary IVL system with the Shockwave C2 coronary IVL catheter in de novo, calcified, stenotic, coronary arteries before stenting.
According to the company, the investigational Shockwave IVL system with the Shockwave C2 coronary IVL catheter, which has been granted Breakthrough Device designation by the FDA, is designed to fracture problematic calcium using sonic pressure waves to facilitate stent delivery, deployment, and optimal expansion.
DISRUPT CAD III is assessing freedom from 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.
The study enrolled 384 patients, exceeding the minimum requirement of 372 patients, per the a priori statistical plan agreed by the FDA. Patients were enrolled at 47 global sites in the United States, France, Germany, and the United Kingdom.
Shockwave C2 coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies. The devices are limited to investigational use in the United States. The company advised it expects that the premarketing approval application will be submitted in the third quarter of 2020, with FDA approval anticipated in the first quarter of 2021, consistent with previous guidance.
The coprincipal investigators of the study are Dean Kereiakes, MD, and Jonathan Hill, MD. Dr. Kereiakes is Medical Director of The Christ Hospital Heart and Vascular Center and the Christ Hospital Research Institute in Cincinnati, Ohio, and Professor of Clinical Medicine, The Ohio State University in Columbus, Ohio. Dr. Hill is Consultant Cardiologist at Royal Brompton Hospital in London, United Kingdom.
The study chairman is Gregg W. Stone, MD, Professor of Medicine at Icahn School of Medicine at Mount Sinai in New York, New York. The angiographic and optical coherence tomography core labs are at the Cardiovascular Research Foundation in New York, New York.
In the company's press release, Dr. Kereiakes commented, “The speed and ease with which we were able to enroll the study speaks volumes to the value of IVL for treating this challenging group of patients with calcified coronary disease. If coronary IVL is shown to be safe and effective, similar to the outcomes demonstrated in the earlier CAD I and CAD II studies, it could be a game changer for the way we treat calcified arteries today.”
Dr. Hill added, “We eagerly await the opportunity to share the DISRUPT CAD III results with the global interventional community later this year. IVL has been a significant advance for our management of calcified lesions in Europe and I am excited about the potential for the technology to have a similar impact in helping patients across the United States.”