A prospective, multi-center, single-group target value method was used in this study. According to the inclusion criteria stipulated in this trial protocol, \> 3 medical device clinical trial institutions with the record of the State Food and Drug Administration were selected as clinical centers, and 190 cases were selected (the first case of each center was taken as the imported case. Follow-up was carried out according to the program process, but the results were analyzed separately. Moderate-to-severe calcified stenosis patients who met all the inclusion criteria and did not meet any exclusion criteria were enrolled into the study. Lumen pretreatment was performed using the coronary shock catheter system and drug-eluting stents were implanted. Subjects were followed up immediately after surgery, before discharge, 30±3 days after surgery, and 6 months ±14 days after surgery to evaluate the safety and effectiveness of coronary lithotripsy catheter system for preconditioning patients with moderate and severe coronary artery calcification stenosis. In this study, the success rate of postoperative surgery was used as the primary endpoint, and major cardiovascular and cerebrovascular adverse events within 30 days after surgery were used as the secondary endpoint. After the completion of the primary endpoint evaluation of the project, it shall be submitted together with other data to the competent department of medical device approval for initial registration. At the same time, continue to complete the follow-up of the subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Subjects who plan to receive possible interventional therapy meet all admission criteria and do not meet any exclusion criteria, and enter the screening stage of this clinical trial after signing informed consent. All subjects who sign the informed consent will be provided with a unique subject screening number. All subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled and lumen pretreated with a coronary shock catheter system followed by the implantation of drug-eluting stents.
Success rate of operation
After the successful passage of the experimental medical device, the residual stenosis rate of the target lesion immediately after the implantation of the drug-eluting stent was less than 50% and no MACE(Major Adverse Cardiovascular Events) occurred in the hospital after the use of the coronary shock catheter system for lumen preparation.
Time frame: Immediately after the procedure
Success rate of contrast
After successful passage of the experimental medical instruments, residual stenosis of the target lesion was \< 50% after preconditioning and there were no serious angiographic complications, including flow limiting dissection (NHLBI grade D-F type)(NHLBI:National Heart, Lung, and Blood Institute) perforation, acute lumen occlusion, and persistent slow flow or no reflow.
Time frame: Immediately after using the test control advice in treatment
Operation success rate 2
After lumen preparation using experimental medical instruments, residual stenosis rate of target lesion after drug eluting stent implantation was less than 50%, blood flow grading was TIMI level 3, and no MACE event occurred during hospitalization.
Time frame: Immediately after using the test control advice in treatment
Residual stenosis rate of target lesions after pretreatment with experimental medical instruments
Time frame: Immediately after the procedure
Residual stenosis rate of target lesions immediately after operation
Time frame: Immediately after the procedure
Thrombolysis In Myocardial Infarction blood flow grading of target lesions immediately after operation
Time frame: Immediately after the procedure
Major adverse cardiovascular events (MACE) event rate
Time frame: Immediately after the procedure、30days、180days
Major adverse cardiovascular and cerebrovascular events (MACCE) event rate
Time frame: Immediately after the procedure、30days、180days
Myocardial infarction rate
Time frame: Immediately after the procedure、30days、180days
Rate of revascularization
Time frame: Immediately after the procedure、30days、180days
Stent thrombosis rate
Time frame: Immediately after the procedure、30days
Lumen diameter was obtained immediately after operation
Time frame: Immediately after the procedure
Luminal area obtained immediately after operation
Time frame: Immediately after the procedure
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