NCT01577888

Safety and Feasibility Study of the Shockwave Lithoplasty System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To study the early safety and performance of the Shockwave Medical System in subjects to demonstrate that the device can safely and effectively deliver localized energy for the treatment of vascular disease.

Detailed description

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, single-center, First in Human study designed to evaluate the early safety and feasibility of the Shockwave Lithoplasty System in subjects with heavily calcified infrainguinal arteries with 3.75mm to 6mm reference vessel diameter at 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 10 subjects will be enrolled to undergo lihtoplasty.

Conditions

• Vascular Disease

Interventions

Type	Name	Description
DEVICE	Shockwave System Treatment	Shockwave System Treatment during vascular disease intervention.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-04-16
• Last updated: 2014-08-08

Locations

1 site across 1 country: New Zealand