This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China. A total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. The success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus.
This is a prospective, multi-center, single-group target value clinical trial to recruit patients with coronary artery calcification, coronary artery calcification was pretreated with balloon dilatation catheter and intracoronary lithotripsy apparatus made by Shanghai Blusail Boyuan Medical Technology Co. , Ltd. , to verify the safety and efficacy of balloon dilatation catheter and intracoronary lithotripsy instrument for intravascular preconditioning of coronary artery calcification lesions. This trial will be carried out in many clinical trial institutions in China, and a total of 184 subjects (70 of them are OCT subgroups) are planned to be enrolled, all subjects were treated surgically with intracoronary lithotripsy using a balloon dilatation catheter and intracoronary lithotripsy apparatus after a single-group registration, clinical follow-up was carried out within 7 days after operation or before discharge, 1 month and 6 months after operation. In this study, the success rate of operation was taken as the main end point to verify the effectiveness of balloon dilatation catheter and intracoronary lithotripsy apparatus. A clinical summary report was issued for registration of the product 1 month after completion of postoperative follow-up, based on which a 6-month postoperative follow-up was performed to assess its safety. The secondary end points were angiographic success, device success, target lesion failure at 1 and 6 months, severe angiographic complications, MACE events at 1 and 6 months, serious adverse events and adverse events, and device defects. In the OCT Subgroup, the secondary end points were the minimum stent area (MSA), the minimum stent lumen diameter (MLD), the lumen acquired diameter, the lumen acquired area, and the lumen acquired rate of the immediate postoperative, the expansion rate of the stent, and the incomplete adherence rate of the stent beam.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Introduction: After the preparation, release the intracoronary lithotripsy balloon catheter to the area to be treated and release the shock wave pulse for treatment. After the balloon reaches the predetermined position, use angiography to lock the position and fill the balloon to 6 atm. After the shock wave pulse therapy, the balloon was expanded to 8 atm according to the balloon compliance table and lasted for 10s. After the treatment, unload the balloon pressure, wait for the blood flow to recover, and repeat the second treatment after an interval of one minute, two cycles, releasing a total of 20 shock wave pulses as a treatment cycle. Therapeutic apparatus specification: IVL-HVG-C01; Specifications of balloon catheter: C20012, C20015, C22512, C22515, C25012, C25015, C27512, C27515, C30012, C30015, C32512, C32515, C35012, C35015, C37512, C37515, C40012, C40015
OCT (optical coherence tomography) measurement using Dragonfly Opstar Imaging Catheter was performed in the OCT subgroup before or after the treatment of intracoronary lithotripsy balloon catheter and intracoronary lithotripsy therapeutic instrument, or after stent placement.
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGMeizhou People's Hospital
Meizhou, Guangdong, China
RECRUITINGCangzhou Central Hospital
Cangzhou, Hebei, China
RECRUITINGthe 980th Hospital of Chinese People's Liberation Army Joint Logistics Support Force
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGFuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGPeople's Hospital of Wuhan University
Wuhan, Hubei, China
NOT_YET_RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGThe Second Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
NOT_YET_RECRUITING...and 10 more locations
Operation success rate
After successful stent placement, the residual stenosis in the stent is ≤ 30%, and there is no residual stenosis during hospitalization (up to 7 days after surgery at most) MACE event occurs
Time frame: During hospitalization (up to 7 days after operation)
Angiographic success rate (residual stenosis ≤ 30%)
Efficacy endpoint
Time frame: Immediately after operation
Incidence rate of MACE events 1 month and 6 months after operation
Security endpoint
Time frame: 6 months after operation
Target lesion failure (TLF) rate 1 month and 6 months after operation
Security endpoint
Time frame: 6 months after operation
Device success rate
Security endpoint
Time frame: 6 months after operation
Incidence of serious angiographic complications
Security endpoint
Time frame: 6 months after operation
Incidence rate of serious adverse events and adverse events
Security endpoint
Time frame: 6 months after operation
Incidence rate of device defects
Security endpoint
Time frame: 6 months after operation
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