3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training (3DforPCI)

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

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Other: Training on coronary angiography using 3D coronary artery simulator

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shubin Qiao, MD,PhD; Phone Number: +8613701237893; Email: qsbfw@sina.com
• Study Contact Backup: Name: Zhuoxuan Yang, MD,PhD; Phone Number: +8618811756722; Email: 525599492@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Less-experienced group; The participant who has completed the number of PCI less than 200 before recruiting	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.
Experimental: Experienced group; The participant who has completed the number of PCI more than 200 before recruiting	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Shubin Qiao, MD,PhD, Fuwai Hospital, Beijing, China

Study record dates

Study Major Dates

• Study Start (Anticipated): June 7, 2020
• Primary Completion (Anticipated): June 7, 2020
• Study Completion (Anticipated): June 10, 2020

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; training; 3D printing; silicone; coronary artery simulator
• Other Study ID Numbers: 2018YFB1107102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: including the simulator details; the basic information of all participants; the scores of all participants before and after training; the training process
• IPD Sharing Time Frame: 6 months after the trail completed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No