Last updated on February 2020

Disrupt CAD IV With the Shockwave Coronary IVL System

Brief description of study

The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting.

Detailed Study Description

Subject Population: Subjects 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention. Approximately 72 subjects at 8 sites in Japan will be enrolled. Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Clinical Study Identifier: NCT04151628

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Kyoto-Katsura Hospital

Kyoto-shi, Japan
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