Coronary Artery Disease Clinical Trial
Official title:
Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.
The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) will be enrolled at up to 20 US sites. Enrollment duration will be approximately 10-12 months and study duration will be approximately 2 years. Each subject will be followed through discharge, 30 days, 6, and 12 months. ;
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