Shockwave Begins DISRUPT CAD III Pivotal Trial of Coronary Intravascular Lithotripsy
January 14, 2019—Shockwave Medical, Inc. announced that it has initiated the pivotal DISRUPT CAD III clinical trial, its FDA investigational device exemption (IDE) study evaluating the use of intravascular lithotripsy (IVL) in heavily calcified coronary arteries. The first patient was enrolled by Richard A. Shlofmitz, MD, at St. Francis Hospital in Roslyn, New York.
DISRUPT CAD III is a prospective, nonrandomized, multicenter, global IDE study that seeks to demonstrate the safety and effectiveness of the company's Shockwave coronary IVL system with the Shockwave C2 coronary IVL catheter in de novo, calcified, stenotic coronary arteries before stenting. The study is expected to enroll approximately 392 patients at 50 global centers in the United States and Europe.
According to the company, the study's primary safety endpoint is freedom from major adverse cardiac events (MACEs) within 30 days of the index procedure. The primary effectiveness endpoint is procedural success, which, based on predicate studies, is defined as stent delivery with a residual stenosis of < 50% and without in-hospital MACEs. Enrolled study patients will be followed for 2 years.
Historically used to treat patients with kidney stones, IVL is a lesion preparation tool that is designed to fracture problematic calcium using sonic pressure waves.
Coronary IVL is intended to facilitate stent delivery, deployment, and expansion. 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 Coprincipal Investigators of the study are Dean Kereiakes, MD, and Jonathan Hill, MD. The study’s Chairman is Gregg W. Stone, MD. The angiographic and optical coherence tomography core labs are located at the Cardiovascular Research Foundation in New York, New York.
In the United States, Shockwave C2 coronary IVL catheters are limited to investigational use. They are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies.
In the company's announcement, Dr. Kereiakes commented, "After previously using the peripheral IVL technology—Shockwave M5—to enable transfemoral access for transcatheter aortic valve replacement as well as for mechanical cardiac support and hearing the enthusiasm from Europe about coronary IVL, we are very excited to investigate the clinical potential of the coronary technology in the United States." He continued, "This therapy holds tremendous potential from a safety perspective for patients and an ease of use perspective for physicians—if coronary IVL is shown to be safe and effective, it could be a game changer for the way we treat calcified arteries today.” Dr. Kereiakes, is with The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati, Ohio.
Dr. Hill, who is with King’s College Hospital in London, United Kingdom, added, “Having treated nearly 100 patients with IVL since its European launch, the benefits for treating complex patients are evident. I am delighted to be a part of this important global trial to introduce my United States interventional colleagues to this novel technology. IVL is easy to use and has been a huge advancement for our management of calcified lesions. I think United States interventionalists will recognize the simplicity and ease of use of the IVL system and will appreciate its ability to be rapidly deployed in any cath lab. I have no doubt that IVL is poised to become the key differentiating technology compared to other calcium modification tools.”