3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training
3DforPCI
1 other identifier
interventional
150
1 country
1
Brief Summary
This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2020
CompletedStudy Start
First participant enrolled
June 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2020
CompletedJune 17, 2020
June 1, 2020
Same day
June 3, 2020
June 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Less-experienced group
EXPERIMENTALThe participant who has completed the number of PCI less than 200 before recruiting
Experienced group
EXPERIMENTALThe participant who has completed the number of PCI more than 200 before recruiting
Interventions
Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.
Eligibility Criteria
You may qualify if:
- Previous experience in coronary intervention
- Understand the process of trail and be willing to participate
You may not qualify if:
- No previous experience with coronary intervention
- Unwilling to participate the trail
- Unable to complete the trail due to other problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Study Officials
- PRINCIPAL INVESTIGATOR
Shubin Qiao, MD,PhD
Fuwai Hospital, Beijing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director,Head of cardiology department
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 9, 2020
Study Start
June 7, 2020
Primary Completion
June 7, 2020
Study Completion
June 10, 2020
Last Updated
June 17, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 6 months after the trail completed
including the simulator details; the basic information of all participants; the scores of all participants before and after training; the training process