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

N

National Center for Cardiovascular Diseases

Status

Unknown

Conditions

Percutaneous Coronary Intervention

Treatments

Other: Training on coronary angiography using 3D coronary artery simulator

Study type

Interventional

Funder types

Other

Identifiers

NCT04420715
2018YFB1107102

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Shubin Qiao, MD,PhD; Zhuoxuan Yang, MD,PhD

Data sourced from clinicaltrials.gov

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