Prospective Multicenter Single-Arm Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD III Study)
Brief description of study
The purpose of this study is to see if the study device is safe and effective in treating narrowed coronary arteries. The objective of this investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary IVL System to treat de novo, calcified, stenotic, coronary lesions prior to stenting. The rationale for this global IDE study is to assess the safety and effectiveness of the Shockwave Coronary IVL System with up to 24 months of follow-up.
Clinical Study Identifier: s19-00287
ClinicalTrials.gov Identifier: NCTs19-00287
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