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Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions — REC-CHIPCAC  

De Novo Stenosis Clinical Trial

Official title:
Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial

Clinical Trial Summary

Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis. Intravascular lithotripsy (IVL), a novel approach for severely calcified coronary lesion preparation, has shown promising preliminary outcomes. Combining IVL with conventional approaches, such as Rotational atherectomy (RA), non-compliant balloons, or cutting balloons, may associated with additional benefit than conventional approaches only in terms of better stent expansion and lower long-term adverse events. This pilot randomized trial aims to investigate whether combining IVL to conventional therapy surpasses the efficacy of conventional approaches alone. The primary effectiveness endpoint is final stent expansion assessed by post-procedure optical coherence tomography (OCT), and the primary safety endpoint is target lesion failure (TVF). The trial seeks to provide valuable insights into the optimal approach for managing severely calcified coronary lesions during PCI.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06238518
Study type Interventional
Source Xijing Hospital
Contact Chao Gao,, M.D, Ph.D
Phone +86-18629551066
Email woshigaochao@gmail.com
Status Recruiting
Phase N/A
Start date January 5, 2024
Completion date March 1, 2025
View Details
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