NCT05552131

Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Suzhou Zhonghui Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Moderate to Severe Calcified Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	T-wave coronary lithotripsy catheter system	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.

Timeline

• Start date: 2022-12-20
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2022-09-23
• Last updated: 2022-12-23