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Clinical Trial Summary

To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.


Clinical Trial Description

At present age, there are few real-world data published about the use of intravascular lithotripsy. Its safety and possible procedural complications remain unclear, and the effects of combination with other plaque-modification devices are unknown. Finally, there are few data about long-term outcomes in the real-life setting. Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with Stable CAD or Acute Coronary Syndromes, that are suitable for percutaneous coronary intervention (PCI). Approximately 400 subjects at 20 sites will be enrolled. Subjects will be followed through discharge, 30 days, 6 and 12 months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05016726
Study type Observational [Patient Registry]
Source SS Annunziata Hospital, Savigliano
Contact MARCO PAVANI, MD
Phone +39 3281598831
Email marcopavani@alice.it
Status Not yet recruiting
Phase
Start date October 1, 2021
Completion date October 30, 2024

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