Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

Fu Jen Catholic University

Status: Enrolling

Conditions: Aortic Aneurysm

Treatments: Other: 3D printed lesion model; Other: historical control

Study type: Interventional

Funder types: Other

Identifiers

NCT06147024

FJUH112284

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

historical control group

Active Comparator group

Description:

conventional preoperative assessment

Treatment:

Other: historical control

3D printed lesion model group

Experimental group

Description:

using 3D printed lesion models for preoperative planning

Treatment:

Other: 3D printed lesion model