Suzhou Zhonghui Medical Technology Co., Ltd.
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.
Moderate to Severe Calcified Coronary Artery Stenosis
T-wave coronary lithotripsy catheter system
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 190 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Coronary Lithotripsy Catheter System for Lumen Preconditioning in Moderate-to-severe Coronary Artery Calcification |
Actual Study Start Date : | December 20, 2022 |
Estimated Primary Completion Date : | May 30, 2024 |
Estimated Study Completion Date : | May 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Coronary lithotripsy catheter system + drug-eluting stent |
Device: T-wave coronary lithotripsy catheter system |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.