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

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT05088291
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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).

Study Timeline

• Study First Submitted: 2021-09-23
• Study Start: 2021-09-30
• Study First Submitted QC: 2021-10-10
• Study First Posted: 2021-10-21
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Consecutive patients were admitted to the group for coronary arteriography (CAG) or percutaneous coronary intervention (PCI).

Exclusion Criteria

• There were no exclusion criteria, and the patients were continuously enrolled for interventional diagnosis and treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cumulative absorbed dose at different heights outside the NPD	After study completion, about 6 months	The 16 thermoluminescent dosimetries (TLD) were placed outside the NPD at a height of 110cm, 90cm, 50cm and 10cm above the ground, with each height divided into four positions (front, back, left and right). After the test, the TLDs were sent to Jiangsu CDC for testing.
The cumulative absorbed dose of the first operator	After study completion, about 6 months	The 16 thermoluminescent dosimetries (TLD) were placed at a height of 110cm, 90cm, 50cm and 10cm above the ground of the first operator (inside NPD or TLC), and each height is divided into four positions. After the test, the TLDs were sent to Jiangsu CDC for testing.
The cumulative absorbed dose at different heights outside the TLC	After study completion, about 6 months	The 12 thermoluminescent dosimetries (TLD) were placed outside the NPD at a height of 110cm, 90cm and 50cm above the ground, with each height divided into four positions (front, back, left and right). After the test, the TLDs were sent to Jiangsu CDC for testing.

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China