New worldwide lithoplasty trial begins PAD patient enrollment

A health care system in Pennsylvania has enrolled the first patient in the US in a trial that will assess whether a new type of technology is effective for arterial blockages in the legs.

PinnacleHealth CardioVascular Institute in Harrisburg, PA, is participating in DISRUPT PAD III, the largest multi-center randomized study to exclusively enroll patients with calcified peripheral artery disease (PAD). In total, the trial will enroll 334 participants around the world.

The goal is to determine the optimal therapy to dilate heavily calcified lesions. Traditional angioplasty will be compared with the Shockwave Medical Lithoplasty System, with a primary goal of achieving less than 30% residual stenosis without the need for stenting. Patients who do not receive a stent will undergo treatment with a drug-coated balloon.

“We are very excited to be the first to treat a US patient in the global study of this cutting edge technology for patients with claudication or pain in the legs due to leg artery blockages,” said William Bachinsky, MD, FACC, Medical Director of Vascular Services at PinnacleHealth CardioVascular Institute. “The Shockwave Medical Lithoplasty device, if proven as a result of this clinical trial, will be a game changer in the treatment of patients with PAD, allowing for low pressure, controlled expansion of blocked artery and potentially less risk for internal tearing of the artery and need for implanting permanent metal stents.”

Lithotripsy has been used for years in patients with kidney stones. Lithoplasty technology delivers localized lithotripsy to treat calcified arteries in patients with PAD.

The device is built on the angioplasty balloon platform. Each catheter has multiple lithotripsy emitters that are activated with the push of a button while the integrated balloon is inflated. These emitters produce inherently tissue-selective soundwaves that pass through the balloon and soft vascular tissue. They preferentially disrupt the calcified plaque by creating a series of microfractures.

After the calcium has been disrupted, the vessel can be dilated with low pressures. This enables even historically challenging cases of PAD to be treated effectively and with minimal injury to the vessel.