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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04420715
Acronym
3DforPCI
Enrollment
150
Registered
2020-06-09
Start date
2020-06-07
Completion date
2020-06-10
Last updated
2020-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Intervention

Keywords

percutaneous coronary intervention, 3D printing, silicone, coronary artery simulator, training

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.

Interventions

OTHERTraining 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.

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the time taken in operationThrough study completion, an average of 4 hoursThe change of time taken to complete the coronary angiography assessment before and after training
Change of the amount of contrast agent usedThrough study completion, an average of 4 hoursThe change of the amount of contrast agent used in the coronary angiography assessment before and after training
Change in assessment scoresThrough study completion, an average of 4 hoursThe 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).

Countries

China

Contacts

Primary ContactShubin Qiao, MD,PhD
qsbfw@sina.com+8613701237893
Backup ContactZhuoxuan Yang, MD,PhD
525599492@qq.com+8618811756722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026