ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification

The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone in patients with moderate-to-severe coronary artery calcification (CAC). Its core research questions are as follows: A. To evaluate whether routine or combined application of shockwave intravascular lithotripsy can effectively reduce the target vessel failure rate in moderate-to-severe coronary artery calcification lesions. B. To evaluate the long-term prognosis of patients with coronary artery calcification. The researchers will compare the experimental group (routine preconditioning plus IVL) and the control group (routine preconditioning alone) to determine whether the combined use of intravascular lithotripsy following routine preconditioning can improve patient prognosis.

NCT Number	NCT07340294
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: First Hospital of China Medical University, The First Affiliated Hospital of Nanchang University, The People's Hospital of Liaoning Province, Tianjin Forth Central Hospital
Conditions	Coronary Artery Calcification, Calcific Coronary Arteriosclerosis
Enrollment	1,096 participants
Start Date	2025-10-24
Primary Completion	2027-11-30 (estimated)
Study Completion	2029-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-14