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

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


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.


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


Peripheral Arterial Disease


Shockwave Lithoplasty® System


Medizinische Universitaet Graz




Shockwave Medical, Inc.

Results (where available)

View Results


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

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