Percutaneous Coronary Intervention3DforPCINCT04420715
3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training
A study testing Training on coronary angiography using 3D coronary artery simulator in people with Percutaneous Coronary Intervention, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Training on coronary angiography using 3D coronary artery simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2020to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Previous experience in coronary intervention
- Understand the process of trail and be willing to participate
Who cannot join
- No previous experience with coronary intervention
- Unwilling to participate the trail
- Unable to complete the trail due to other problems
Trial locations and contacts
1 site in 1 country.
About this study
This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.
Read the 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.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Training on coronary angiography using 3D coronary artery simulator
- Keywords
- percutaneous coronary intervention, 3D printing, silicone, coronary artery simulator, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on coronary angiography using 3D coronary artery simulatorOther
Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.
| Study group | Role | What they receive |
|---|---|---|
| Less-experienced group | Experimental | The participant who has completed the number of PCI less than 200 before recruiting Receives: Other: Training on coronary angiography using 3D coronary artery simulator |
| Experienced group | Experimental | The participant who has completed the number of PCI more than 200 before recruiting Receives: Other: Training on coronary angiography using 3D coronary artery simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the time taken in operation
The change of time taken to complete the coronary angiography assessment before and after training
Measured: 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
Measured: 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).
Measured: Through study completion, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start7 Jun 2020 (estimated)
- Primary completion7 Jun 2020 (estimated)
- Study completion10 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shubin_Qiao, Fu Wai Hospital, Beijing, China
- Investigators
- Shubin Qiao, MD,PhD, Principal investigator, Fuwai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420715
- Sponsor's protocol ID
- 2018YFB1107102
- Acronym
- 3DforPCI
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: including the simulator details; the basic information of all participants; the scores of all participants before and after training; the training process
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training
- ClinicalTrials.gov ID
- NCT04420715
- Acronym / sponsor ID
- 3DforPCI / 2018YFB1107102
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- percutaneous coronary intervention, 3D printing, silicone, coronary artery simulator, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 7 Jun 2020 (estimated)
- Primary completion
- 7 Jun 2020 (estimated)
- Study completion
- 10 Jun 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less-experienced group | Experimental | Other: Training on coronary angiography using 3D coronary artery simulatorThe participant who has completed the number of PCI less than 200 before recruiting |
| Experienced group | Experimental | Other: Training on coronary angiography using 3D coronary artery simulatorThe participant who has completed the number of PCI more than 200 before recruiting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Previous experience in coronary intervention
- Understand the process of trail and be willing to participate
Key exclusion criteria (3 listed)
- No previous experience with coronary intervention
- Unwilling to participate the trail
- Unable to complete the trail due to other problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on coronary angiography using 3D coronary artery simulatorParticipants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective. | Other | Experienced group, Less-experienced group |
Primary outcome
Change of the time taken in operation
Time frame: Through study completion, an average of 4 hours
The change of time taken to complete the coronary angiography assessment before and after training
Change of the amount of contrast agent used
Time frame: Through study completion, an average of 4 hours
The change of the amount of contrast agent used in the coronary angiography assessment before and after training
Change in assessment scores
Time frame: Through study completion, an average of 4 hours
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Yes. including the simulator details; the basic information of all participants; the scores of all participants before and after training; the training process
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubin Qiao, MD,PhD principal investigator
Fuwai Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on coronary angiography using 3D coronary artery simulator in people with Percutaneous Coronary Intervention, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shubin Qiao, MD,PhD (+8613701237893, qsbfw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the time taken in operation (time frame: Through study completion, an average of 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.