Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
Completed · Not applicable
Conditions studied: Coronary Artery Disease, Myocardial Infarction
In brief
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.
Key facts
- Study ID
- NCT05966662
- Run by
- Shockwave Medical, Inc.
- People needed
- 145
- Starts
- 2023-12-08
- Expected to finish
- 2025-12-19
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Heart Center Research — Huntsville, Alabama, United States
- Scripps Clinic — La Jolla, California, United States
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Memorial Health — Hollywood, Florida, United States
- Wellstar Kennestone Hospital — Marietta, Georgia, United States
- Loyola University — Chicago, Illinois, United States
- Norton Heart and Vascular Institute — Louisville, Kentucky, United States
- Essentia Health St. Mary's Heart & Vascular Center — Duluth, Minnesota, United States
- Washington University — St Louis, Missouri, United States
- Northwell Health/Lenox Hill — New York, New York, United States
- St. Francis Hospital — Roslyn, New York, United States
- The Christ Hospital — Cincinnati, Ohio, United States
- UPMC Pinnacle Health — Harrisburg, Pennsylvania, United States
- WellSpan Health - York — York, Pennsylvania, United States
- Baylor Scott and White Research Institute — Dallas, Texas, United States
- Methodist Hospital — San Antonio, Texas, United States
- Swedish Medical Center — Seattle, Washington, United States
- Charleston Area Medical Center — Charleston, West Virginia, United States
Full record on ClinicalTrials.gov
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