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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
Medizinische Universitaet Graz
Graz, Austria
Hanusch Krankenhaus
Vienna, Austria
Department of Angiology - Universitats Herzzentrum Freiburg
Bad Krozingen, Baden-Wurttemberg, Germany
Auckland City Hospital
Auckland, New Zealand
Composite of new-onset Major Adverse Events (MAE)
Death Myocardial infarction Need for emergency surgical revascularization of the target limb. Amputation of target limb.
Time frame: Procedure through 30 days post procedure
Efficacy
Acute reduction in percent (%) diameter stenosis of target lesion
Time frame: Peri-Procedural
Procedural Success
The ability of the Shockwave Lithoplasty® System to achieve a post-shockwave residual diameter stenosis of ≤50%
Time frame: Peri-Procedural
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