Shockwave Completes Enrollment of Disrupt CAD II Study

Shockwave Medical ( NASDAQ:SWAV) has announced it has completed enrollment of its DISRUPT CAD II study.

As quoted in the press release:

DISRUPT CAD II is a prospective, non-randomized, multicenter, real-world study to confirm the safety and performance results from the DISRUPT CAD I study, which was used to obtain European approval of the Shockwave Coronary IVL System. DISRUPT CAD II enrolled more patients (120) with de novo, calcified, stenotic, coronary arteries at more European centers (15) than the first study (60 patients and 7 centers, respectively) to determine if the pervious strong safety results could be replicated in more patients and with more operators in a real-world setting.

The study’s primary safety endpoint is freedom from in-hospital major adverse cardiac events (MACE); patients will also be followed out to 30 days per the protocol. The co-principal investigators are Professor Jean Fajadet of Clinique Pasteur in Toulouse, France and Professor Carlo Di Mario of University of Florence in Florence, Italy, who also had the largest enrollment with 16 patients.

“While DISRUPT CAD I enrolled a limited number of patients, its safety results were quite compelling to those of us who treat challenging calcified lesions on a daily basis,” said Professor Fajadet. “If DISRUPT CAD II can confirm the safety results found in the first study, I think it will help establish IVL as a new standard in safety that operators can expect when treating patients with challenging, heavily calcified coronary artery disease. We look forward to sharing these data with our colleagues as soon as possible.”

Click here to read the full press release.