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Clinical Trials/NCT04420715
NCT04420715
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N/A

3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training

China National Center for Cardiovascular Diseases1 site in 1 country150 target enrollmentJune 7, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Percutaneous Coronary Intervention
Sponsor
China National Center for Cardiovascular Diseases
Enrollment
150
Locations
1
Primary Endpoint
Change of the time taken in operation
Last Updated
5 years ago

Overview

Brief Summary

This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.

Detailed Description

With the aging of the population, the incidence of cardiovascular diseases has exceeded that of respiratory diseases and cancer, corresponding to the rapid increase in the number of coronary stent implantation. Therefore, the standardized training of interventional cardiologists is particularly important. Nowadays percutaneous coronary intervention (PCI) training mode is mainly for the trainees to operate on the patients under the experienced operator. Although this kind of training method can truly show the operation process, it has obvious limitations. For beginners, it takes repeated training and revision to achieve proficiency and accuracy.Learning only through real surgery may result in longer operative times, increased radiation exposure, and increased complications.This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.

Registry
clinicaltrials.gov
Start Date
June 7, 2020
End Date
June 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Responsible Party
Principal Investigator
Principal Investigator

Shubin_Qiao

Director,Head of cardiology department

Fu Wai Hospital, Beijing, China

Eligibility Criteria

Inclusion Criteria

  • Previous experience in coronary intervention
  • Understand the process of trail and be willing to participate

Exclusion Criteria

  • No previous experience with coronary intervention
  • Unwilling to participate the trail
  • Unable to complete the trail due to other problems

Outcomes

Primary Outcomes

Change of the time taken in operation

Time Frame: Through study completion, an average of 4 hours

The change of time taken to complete the coronary angiography assessment before and after training

Change of the amount of contrast agent used

Time Frame: Through study completion, an average of 4 hours

The change of the amount of contrast agent used in the coronary angiography assessment before and after training

Change in assessment scores

Time Frame: Through study completion, an average of 4 hours

The change of scores of "Rating scale of coronary angiography operation assessment" before and after training. The assessment includes operation integrity, standardization, proficiency, accuracy,etc. Every point contain 5 different levels from the worst(1) to the best(5).

Study Sites (1)

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