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

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

Detailed Description
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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.

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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Other: Training on coronary angiography using 3D coronary artery simulator


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Less-experienced group<br>The participant who has completed the number of PCI less than 200 before recruiting | Other: Training on coronary angiography using 3D coronary artery simulator<br>* Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.<br>|
| Experimental: Experienced group<br>The participant who has completed the number of PCI more than 200 before recruiting | Other: Training on coronary angiography using 3D coronary artery simulator<br>* Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the time taken in operation | The change of time taken to complete the coronary angiography assessment before and after training | Through study completion, an average of 4 hours | 
| Change of the amount of contrast agent used | The change of the amount of contrast agent used in the coronary angiography assessment before and after training | Through study completion, an average of 4 hours | 
| Change in assessment scores | 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). | Through study completion, an average of 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, 3D printing, silicone, coronary artery simulator, training