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

Not Applicable

• Conditions: Percutaneous Coronary Intervention
• Interventions: Other: Training on coronary angiography using 3D coronary artery simulator

• 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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-04
• Study Start: 2020-06-07
• Primary Completion: 2020-06-07
• Study First Posted: 2020-06-09
• Study Completion: 2020-06-10
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17

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

Arm && Interventions

Group	Intervention	Description
Less-experienced group	Training on coronary angiography using 3D coronary artery simulator	The participant who has completed the number of PCI less than 200 before recruiting
Experienced group	Training on coronary angiography using 3D coronary artery simulator	The participant who has completed the number of PCI more than 200 before recruiting

Primary Outcome Measures

Name	Time	Method
Change of the time taken in operation	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	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	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).

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China