Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

Not Applicable

Recruiting

• Conditions: Aortic Aneurysm
• Interventions: Other: historical control; Other: 3D printed lesion model

• Registration Number: NCT06147024
• Lead Sponsor: Fu Jen Catholic University

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

Study Timeline

• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-27
• Study Start: 2024-04-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-05
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-10-05
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
historical control group	historical control	conventional preoperative assessment
3D printed lesion model group	3D printed lesion model	using 3D printed lesion models for preoperative planning

Primary Outcome Measures

Name	Time	Method
surgical time	immediately after the surgical procedure	the duration of the surgical procedure

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan