This article is more than 5 years old. Information may no longer be current.
New trial launched for system to treat calcified lesions in patients with PAD
Shockwave Medical announced the first patient has been enrolled in a post-market trial to assess superiority of a system to treat calcified plaque in patients with peripheral artery disease.
The company also announced the first patient in a U.S. commercial case has been treated with the system (Lithoplasty System).
The system uses lithotripsy, or sonic pressure waves, which historically has been used to treat people with kidney stones, to treat calcified plaque, according to a press release issued by the company. It is approved for use in the U.S. and Europe for treatment of PAD.
Edward Pavillard, DO, a vascular surgeon at Pottstown Memorial Medical Center, Pennsylvania, was the first to use the system to treat a patient with PAD in the U.S.
“The Lithoplasty System is a significant advancement in the treatment of PAD, as it provides a new treatment option with potentially less risk of damage or injury to the vessel,” Pavillard said in the release.
For the post-market trial, DISRUPT PAD III, researchers will assess the safety and efficacy of the system vs. traditional angioplasty. The goal of the study is to achieve less than 30% residual stenosis without the need for stenting. Participants who do not receive a stent will be treated with a drug-coated balloon.
The trial has enrolled its first patient and plans to enroll 334 across 45 global sites, which would make it the largest multicenter randomized trial of patients with heavily calcified PAD, according to the release.
“Patients with challenging heavily calcified PAD have been excluded from previous [DCB] trials,” Marianne Brodmann, MD, of the Medical University of Graz, Austria, who enrolled the first patient, said in the release. “The results of the DISRUPT PAD III randomized trial will bear important implications for treatment of this very important patient population.”
Disclosure: Brodmann reports receiving speaking honoraria from Bayer Health Care, Boehringer Ingelheim, C.R. Bard, Daiichi Sankyo and Medtronic; participating on scientific advisory boards for Intact Vascular, Medtronic and Spectranetics; and serving as an investigator for a trial sponsored by Shockwave Medical. Pavillard reports no relevant financial disclosures.