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

Not Applicable
Conditions
Percutaneous Coronary Intervention
Registration Number
NCT04420715
Lead Sponsor
China National Center for Cardiovascular Diseases
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in assessment scoresThrough 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).

Change of the time taken in operationThrough 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 usedThrough 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Fuwai Hospital

🇨🇳

Beijing, Beijing, China

Fuwai Hospital
🇨🇳Beijing, Beijing, China

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