Distrupt Stiffness Trial

"The device under investigation is the Peripheral Lithotripsy System (Shockwave Medical, Fremont, California). Miniaturized and arrayed lithotripsy emitters create a localized field effect at the site of the calcium. The Peripheral Lithotripsy System is CE-marked for peripheral arterial disease and for this study, will be used within its indication for use. This included the following: intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral and popliteal arteries.~The IVL catheter is delivered across a calcified lesion over an 0.014'' wire and the integrated balloon is expanded to 4atm to facilitate efficient energy transfer.~An electrical discharge from the emitters vaporizes the fluid within the balloon, creating a rapidly expanding and collapsing bubble that generates sonic pressure waves. The waves create a localized field effect that travels through soft vascular tissue,"

Standard of Care