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Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis

2016-09-22 20:53:25 | BioPortfolio

Summary

To observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized pulsatile mechanical energy for balloon dilation of calcified, stenotic, infrapopliteal arteries.

Description

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the early safety and performance of the Shockwave Lithoplasty® System in subjects with moderate to heavily calcified peripheral arteries with 2.5mm to 3.5mm reference vessel diameter at the target site. The Shockwave Lithoplasty® System is indicated for lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to twenty subjects will be enrolled and treated with Lithoplasty® System.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Peripheral Arterial Disease

Intervention

Shockwave Lithoplasty® System

Location

Medizinische Universitaet Graz
Graz
Austria
8036

Status

Recruiting

Source

Shockwave Medical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-22T20:53:25-0400

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