News | Peripheral Artery Disease (PAD) | April 12, 2017

First U.S. Patient Treated in DISRUPT PAD III Study of Lithoplasty Technology

PinnacleHealth CardioVascular Institute offers new treatment option for leg artery blockages

First U.S. Patient Treated in DISRUPT PAD III Study of Lithoplasty Technology

April 12, 2017 — PinnacleHealth CardioVascular Institute last week enrolled the first patient in the United States in a trial assessing the safety and effectiveness of a new type of approach for blockages in the leg artery.

DISRUPT PAD III is the largest ever multi-center randomized study to exclusively enroll patients with calcified peripheral artery disease (PAD). The objective of the trial is to assess the optimal therapy to dilate heavily calcified lesions by comparing the Shockwave Medical Lithoplasty System versus traditional angioplasty, with a primary goal of achieving less than 30 percent residual stenosis without the need for stenting. In addition, all patients who do not receive a stent will be treated with a drug-coated balloon. The trial will enroll 334 patients in up to 45 global sites. William Bachinsky, M.D., FACC, medical director of vascular services at PinnacleHealth CardioVascular Institute, serves locally as principal investigator at PinnacleHealth.

Watch the VIDEO: Breaking Up Calcified Lesions Without Vessel Trauma

Peripheral artery disease (PAD) is the narrowing or blockage of vessels that carry blood from the heart to the extremities. Caused by the buildup of plaque and calcium within the walls of arteries, PAD occurs primarily in the legs, but can be found in vessels throughout the body. 

Balloon angioplasty involves inflating a balloon within the artery at the area of narrowing and expanding the artery to alleviate the blockage. Many patients do not respond well to angioplasty alone, with failure rates as high as 50 percent often due to hardened calcium within the wall of the artery. 

"We are very excited to be the first to treat a U.S. 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 Bachinsky. "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 uses high-speed pressure waves to disrupt calcium and has been used for years in treating patients with kidney stones. Lithoplasty Technology delivers localized lithotripsy for the treatment of calcified arteries in patients with PAD. Built on an angioplasty balloon platform, each catheter incorporates multiple lithotripsy emitters activated with the touch of a button while the integrated balloon is inflated. Once activated, these emitters produce therapeutic sound waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque by creating a series of micro-fractures. Once the calcium has been disrupted, the vessel can be effectively dilated using low pressures thereby enabling even historically challenging PAD patients to be treated effectively and with minimal injury to the vessel.

The DISRUPT PAD III Study is one of more than 50 clinical trials for cardiovascular care currently underway at PinnacleHealth.

For more information: www.shockwavemedical.com

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Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

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