Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

What is the purpose of this trial?

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of 334 subjects (167 per treatment arm) will be enrolled in the study.


Participation Guidelines

Ages: 18 years and older

Gender: Both


Shockwave Medical Inc.

Dates: 05/02/2017 - 04/30/2018

Last Updated: 05/10/2017

Study HIC#: 2000020571

Get Involved

For more information about this study, contact:
Jacqueline Marie Gamberdella
203-737-1899
jacqueline.gamberdella@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Carlos Ignacio Mena

Principal Investigator

Sub-Investigators