Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.
Age range: 18-80 years old, male or non pregnant female
The patient or guardian can voluntarily sign and understand the informed consent form, and can accept follow-up
Asymptomatic ischemic, stable or unstable angina or myocardial infarction (MI) (including ST segment elevation and non ST segment elevation MI) with chest pain onset to hospital admission time>24 hours, as well as old myocardial infarction patients
Visually assess the target lesion with a reference vessel diameter of 2.5-4.0mm, diameter stenosis degree ≥ 70% or ≥ 50%, and evidence of ischemia
Individuals with abnormal coagulation function tests
Patients with severe hemodynamic disorders
Clinical manifestations of heart failure with LVEF<30%
I have experienced an acute myocardial infarction in the past week
Parallel
intravascular lithotripsy
DeviceThe intravascular lithotripsy can intermittently release acoustic pressure waves at the site of vascular calcification lesions, thereby achieving the goal of rupturing calcified plaques; After the rupture of calcified plaques, the vascular calcification lesions can be fully dilated with the help of lower balloon inflation pressure.
high-pressure ballon
DeviceHigh pressure balloon dilation, as the main method for traditional treatment of insufficient stent expansion caused by calcification, has a good therapeutic effect on insufficient stent expansion caused by calcification
Satisfaction Rate of Stent Expansion[Effcacy]
Satisfied stent expansion is defined as meeting the standard of good expansion after stent implantation through IVUS after PCI
Major Cardiovascular Events[Effcacy]
a composite endpoint of cardiovascular death, target vessel myocardial infarction and target vessel revascularization
Lumen Obtainment after PCI[Effcacy]
changes in lumen area after treatment
Incidence of Treatment-Emergent Complications[Safety]
Postoperative complications such as coronary spasm, dissection, acute occlusion, persistent ventricular arrhythmia, etc
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