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

Percutaneous Coronary Intervention Clinical Trial

— 3DforPCI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04420715
• Other study ID #: 2018YFB1107102
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 7, 2020
• Est. completion date: June 10, 2020

Study information

• Verified date: June 2020
• Source: China National Center for Cardiovascular Diseases
• Contact: Shubin Qiao, MD,PhD
• Phone: +8613701237893
• Email: qsbfw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 10, 2020
• Est. primary completion date: June 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Other:
• Training on coronary angiography using 3D coronary artery simulator
Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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