At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)
In Brief
A clinical study evaluating Shockwave Lithoplasty System for Peripheral Arterial Disease. Completed, enrolled 60 participants across 8 sites in 3 countries.
Detailed Summary
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty™ System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty™ System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to sixty (60) subjects will be enrolled and treated with Lithoplasty to yield thirty (51) evaluable subjects complete the study assuming a 15% lost to follow-up rate.