NCT05088291

Application of a New X-ray Protective Device in Coronary Interventional Therapy

Effectiveness of a New X-ray Protection Devices in Reducing Radiation in Coronary Intervention Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective and controlled clinical trial which will enroll 200 coronary arteriography or percutaneous coronary intervention with 2-4 interventional cardiologist. The interventional cardiologist performed 100 interventional procedures using either a new protective device (NPD) or a traditional lead clothing (TLC). The cumulative dose outside the NPD or TLC and the first operator at each height (110cm, 90cm, 50cm, 10cm) was measured. The main indicators of the study are the average X-ray shielding efficiency of the NPD and the TLC at four different heights. The investigators will record all operation information in this study.

Detailed description

In this study, the investigators developed a new protection device (NPD) and compared its effects on the reduction of radiation exposure compared with the traditional lead clothing (TLC). The NPD (WLXP-006, Yingnuoweite Medical Science and Technology, Co., Ltd., Nanjing, China) is a floor-standing medical radiation protection device mainly composed of a barrel-like frame and protective lead rubber (0.5 mm lead equivalent).

Conditions

• Coronary Heart Disease

Timeline

• Start date: 2021-09-30
• Primary completion: 2022-06-30
• Completion: 2022-07-30
• First posted: 2021-10-21
• Last updated: 2023-02-09

Locations

1 site across 1 country: China