The first-phase study is a prospective, single-group observational study. It plans to recruit patients with in-stent restenosis caused by poor stent expansion in the coronary artery. The intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. will be used for treatment. This is a clinical trial to verify the feasibility, preliminary safety and effectiveness of treating in-stent restenosis caused by poor stent expansion in the coronary artery. The second-phase study is a prospective, multicenter, randomized controlled clinical trial is planned to recruit patients with in - stent restenosis caused by poor coronary stent expansion. These patients will be treated with either the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd., or a non - compliant balloon dilation catheter (Shandong JW Medical Products Co., Ltd., National Medical Device Registration No. 20213031019). The purpose is to verify the safety and effectiveness of the investigational medical devices in treating in - stent restenosis caused by poor coronary stent expansion.
In the first phase, it will be carried out at Beijing Luhe Hospital, Capital Medical University. A total of 10 subjects are planned to be enrolled. After the subjects are included in the study, they will be treated with the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. Clinical follow-ups will be conducted before discharge and one month after the operation. In the second phase, it will be carried out at multiple clinical trial institutions in China. A total of 200 subjects are planned to be enrolled. After randomization, all subjects will undergo surgical treatment using either the investigational device or the control device. Clinical follow - up will be conducted before discharge, 1 month after surgery, and 6 months after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Randomly assign subjects to the experimental group to treat the lesions with an intravascular shockwave therapy device/disposable coronary artery shockwave catheter.
Randomly assign subjects to the control group to treat the lesions with a non - compliant balloon catheter.
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Surgical success rate
The residual stenosis after the operation is ≤ 30%, and there is no occurrence of Major Adverse Cardiac Events (MACE) during the hospitalization period (up to 7 days after the operation).
Time frame: during the hospitalization period (up to 7 days after the operation).
Device success rate
Security endpoint
Time frame: Immediately after the operation
The minimum stent area immediately after the operation(MSA)
Measured by Optical Coherence Tomography (OCT)
Time frame: Immediately after the operation
The minimum stent lumen diameter immediately after the operation(MLD)
Measured by Optical Coherence Tomography (OCT)
Time frame: Immediately after the operation
The incidence of Major Adverse Cardiovascular Events (MACE)
Safety endpoint
Time frame: before discharge, one month after the operation
The incidence of target lesion failure (TLF)
Safety endpoint
Time frame: one month after the operation
The incidence of serious adverse events
Safety endpoint
Time frame: before discharge, one month after the operation
The incidence of device defects
Safety endpoint
Time frame: during the operation
The incidence of serious angiographic complications
Safety endpoint
Time frame: during the operation
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