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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05088291

Collaborator

The First People's Hospital of Lianyungang (Other)

200

Enrollment

Location

Anticipated Duration (Months)

22.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
The new protection device A total of 100 patients underwent continuous coronary angiography (CAG) or percutaneous coronary intervention (PCI). The first surgeon does not need to wear a lead dress to stand inside the new protective device (NPD) to perform all operations.
The traditional lead clothing A total of 100 patients underwent continuous coronary angiography (CAG) or percutaneous coronary intervention (PCI). The first surgeon wears the traditional lead clothing (TLC) to perform all operations.

Outcome Measures

Primary Outcome Measures

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 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.
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.