Skip to main content
OpenTrials
Completed

NCT Number: NCT05088291

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The cumulative absorbed dose at different heights outside the NPD

    Time frame: 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.

  2. The cumulative absorbed dose at different heights outside the TLC

    Time frame: 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.

  3. The cumulative absorbed dose of the first operator

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • The First People's Hospital of Lianyungang

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.