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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Coronary Heart Disease

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The new protection device<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative absorbed dose at different heights outside the NPD | 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. | After study completion, about 6 months | 
| The cumulative absorbed dose at different heights outside the TLC | 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. | After study completion, about 6 months | 
| The cumulative absorbed dose of the first operator | 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. | After study completion, about 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiology, coronary angiography, coronary angioplasty, percutaneous coronary intervention, radiation