Last updated on November 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. Disrupt CAD III is being conducted as a staged pivotal study.

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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Piedmont Heart Institute

Atlanta, GA United States
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Northwestern University

Chicago, IL United States
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St. Francis Hospital

Roslyn, NY United States
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The Christ Hospital

Cincinnati, OH United States
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Bryn Mawr Hospital

Bryn Mawr, PA United States
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Scripps Clinic

La Jolla, CA United States
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NC Heart and Vascular

Raleigh, NC United States
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The Miriam Hospital

Providence, RI United States
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Minneapolis Heart Institute

Minneapolis, MN United States
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Honor Health

Scottsdale, AZ United States
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Houston Methodist Hospital

Houston, TX United States
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Henry Ford Hospital

Detroit, MI United States
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St. Joseph Hospital

Orange, CA United States
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Yale New Haven Hospital

New Haven, CT United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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Deborah Heart and Lung Center

Browns Mills, NJ United States
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Geisinger Medical Center

Danville, PA United States
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University of Vermont

Burlington, VT United States
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