NCT02071108

Safety and Performance Study of the Shockwave Lithoplasty System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries.

Detailed description

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 thirty-five (35) subjects will be enrolled and treated with Lithoplasty to yield thirty (30) evaluable subjects complete the study assuming a 15% lost to follow-up rate.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Shockwave Lithoplasty System

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2015-03-01
• First posted: 2014-02-25
• Last updated: 2017-03-24
• Results posted: 2016-10-11

Locations

3 sites across 3 countries: Austria, Germany, New Zealand