Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Aortic Aneurysm

Intervention / Treatment
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* Other: historical control
* Other: 3D printed lesion model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: historical control group<br>conventional preoperative assessment | Other: historical control<br>* Received a conventional preoperative assessment<br>|
| Experimental: 3D printed lesion model group<br>using 3D printed lesion models for preoperative planning | Other: 3D printed lesion model<br>* Received 3D printed lesion models for preoperative planning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical time | the duration of the surgical procedure | immediately after the surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D printing, pre-operative planning, thoracic aorta aneurysm, abdominal aorta aneurysm