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

Coronary Heart Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05088291
Study type Observational
Source The First Affiliated Hospital with Nanjing Medical University
Contact
Status Completed
Phase
Start date September 30, 2021
Completion date July 30, 2022
View Details
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