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

NCT ID: NCT04420715

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-07

Study Completion Date

2020-06-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Less-experienced group

The participant who has completed the number of PCI less than 200 before recruiting

Group Type EXPERIMENTAL

Training on coronary angiography using 3D coronary artery simulator

Intervention Type OTHER

Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.

Experienced group

The participant who has completed the number of PCI more than 200 before recruiting

Group Type EXPERIMENTAL

Training on coronary angiography using 3D coronary artery simulator

Intervention Type OTHER

Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shubin_Qiao

Director,Head of cardiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shubin Qiao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, Beijing, China

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Shubin Qiao, MD,PhD

Role: CONTACT

+8613701237893

Zhuoxuan Yang, MD,PhD

Role: CONTACT

+8618811756722

Other Identifiers

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2018YFB1107102

Identifier Type: -

Identifier Source: org_study_id

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