This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). 266 subjects at 11 sites will be enrolled.Subjects will be followed through discharge, 30 days, 6months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
266
SONICO-CX® balloon matched 1:1 to the reference vessel diameter, was advanced to the target lesion to pretreat
First Affiliated Hospital of University of Science and Technology of China,
Hefei, Anhui, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Procedural success rate
defined as successful stent implantation with ≤30% in-stent residual stenosis and the absence of in-hospital MACE, including cardiac death, MI, and target vessel revascularization
Time frame: During hospitalization (up to 7 days after operation)
Angiography success rate
Angiographic success was defined as successful stent implantation with ≤30% in-stent residual stenosis and without serious angiographic complications immediately after IVL, including type D to F severe dissection, perforation, acute occlusion, sustained slow-flow, or no-reflow
Time frame: Immediately after operation
Device success rate
Device success was defined as the IVL catheter successfully crossing the target lesion and delivering lithotripsy without serious angiographic complications immediately following the procedure
Time frame: Immediately after operation
MACE events
MACE--a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)
Time frame: before discharge, 30 days and 6 months post-procedural
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Meizhou People's Hospital
Meizhou, Guangdong, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, China
...and 1 more locations