NCT06147024

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fu Jen Catholic University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Aortic Aneurysm

Interventions

Type	Name	Description
OTHER	historical control	Received a conventional preoperative assessment
OTHER	3D printed lesion model	Received 3D printed lesion models for preoperative planning

Timeline

• Start date: 2024-04-08
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2023-11-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Taiwan