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Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

Utilizing 3D Printed Personalized Aortic Lesion Models to Assist Surgeons in Preoperative Assessment and Planning of Aortic Aneurysm Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06147024
Enrollment
10
Registered
2023-11-27
Start date
2024-04-08
Completion date
2027-07-31
Last updated
2026-02-27

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

Conditions

Aortic Aneurysm

Keywords

3D printing, pre-operative planning, thoracic aorta aneurysm, abdominal aorta aneurysm

Brief 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.

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

Interventions

Received a conventional preoperative assessment

OTHER3D printed lesion model

Received 3D printed lesion models for preoperative planning

Sponsors

Fu Jen Catholic University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
surgical timeimmediately after the surgical procedurethe duration of the surgical procedure

Countries

Taiwan

Contacts

CONTACTKe-Yun Chao, PhD
C00152@mail.fjuh.fju.edu.tw+886905301879
PRINCIPAL_INVESTIGATORKe-Yun Chao, PhD

Fu Jen Catholic University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026