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RecruitingNCT06147024Updated Feb 27, 2026

Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

An interventional study of historical control and 3D printed lesion model in Aortic Aneurysm, sponsored by Fu Jen Catholic University. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Fu Jen Catholic University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Using 3D printing technology to create personalized models of diseased heart and aortic blood vessels, surgeons can perform preoperative planning and evaluate relevant indicators.

Read the detailed description

Background: Previous systematic reviews have indicated that approximately 82% of surgeries using 3D printed lesion models for preoperative planning have shown better surgical outcomes, and about half of the surgeries have demonstrated reduced operative time. In recent years, there have been numerous studies focusing on the application of 3D printing technology in aortic aneurysms. This study aims to employ 3D printing technology to fabricate personalized aortic blood vessel models with lesions.

Study Design: A single-centre, pilot study.

Methods: This study is a single-center, prospective clinical trial. The study plans to enroll 10 participants in the experimental group, and collect data from another 10 participants as the historical control group. The historical control group data will be matched-paired based on gender, age, and surgical type in sequential order.

Effect: We anticipate that through the use of 3D printed lesion models, we can reduce surgical time, decrease surgery-related complications, and enhance the smoothness of surgical team preparation for the procedure. Additionally, this approach can provide patients with a better understanding of their own condition and the upcoming surgical intervention.

Key words: 3D printing; pre-operative planning; thoracic aorta aneurysm; abdominal aorta aneurysm

02

Conditions studied

  • Aortic Aneurysm

Keywords

  • 3D printing
  • pre-operative planning
  • thoracic aorta aneurysm
  • abdominal aorta aneurysm
03

In context

Aortic Aneurysm

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's planned enrollment of 10 is below the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

Fu Jen Catholic University is the lead sponsor of 47 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with thoracic or abdominal aortic aneurysm
  • Signed surgical consent
  • Non-emergent surgery
  • Had 2D CT imaging within the last 6 months

Exclusion criteria

Exclusion Criteria:

  • Refusal to use lesion images for model creation
  • Refusal to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    historical control group

    conventional preoperative assessment

    Other: historical control

  • Experimental
    3D printed lesion model group

    using 3D printed lesion models for preoperative planning

    Other: 3D printed lesion model

Interventions

  • Otherhistorical control

    Received a conventional preoperative assessment

  • Other3D printed lesion model

    Received 3D printed lesion models for preoperative planning

06

What researchers measure

Primary outcomes

  1. surgical time

    the duration of the surgical procedure

    Time frame: immediately after the surgical procedure

07

Study locations

1 of 1 sites recruiting
  • Fu Jen Catholic University Hospital, Fu Jen Catholic University
    New Taipei City, 24352, Taiwan
    Recruiting
    • Ke-Yun Chao, PhD · Contactck_qq@hotmail.com · +886-905-301-879
    • Ke-Yun Chao, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Jul 2027, 39 months after the start.

Of 44 interventional studies with no phase under Aortic Aneurysm, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 70. This study's planned 39 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2023
First posted
Nov 27, 2023
StartActual
Apr 8, 2024
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06147024
Lead sponsor
Fu Jen Catholic University
Responsible party
Ke-Yun, Chao (Group leader of Respiratory Therapists, Fu Jen Catholic University) — Principal investigator
First posted
Nov 27, 2023
Start date
Apr 8, 2024
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

Ke-Yun Chao, PhD
Contact
C00152@mail.fjuh.fju.edu.tw
+886905301879
Ke-Yun Chao, PhD
principal investigator · Fu Jen Catholic University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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