Last updated on June 2019

Disrupt CAD III With the Shockwave Coronary IVL System


Brief description of study

The study design is a prospective, multicenter, single-arm, global IDE 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 (PCI). Approximately 392 subjects at 50 sites will be enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Clinical Study Identifier: NCT03595176

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St. Francis Hospital

Roslyn, NY United States
1.32miles
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Recruitment Status: Open


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