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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05088291
Enrollment
200
Registered
2021-10-21
Start date
2021-09-30
Completion date
2022-07-30
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

cardiology, coronary angiography, coronary angioplasty, percutaneous coronary intervention, radiation

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).

Interventions

None listed

Sponsors

The First People's Hospital of Lianyungang
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* There were no

Design outcomes

Primary

MeasureTime frameDescription
The cumulative absorbed dose at different heights outside the NPDAfter study completion, about 6 monthsThe 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 TLCAfter study completion, about 6 monthsThe 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 operatorAfter study completion, about 6 monthsThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026