NCT06147024

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Apr 2024Jul 2027

First Submitted

Initial submission to the registry

November 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

November 20, 2023

Last Update Submit

February 25, 2026

Conditions

Aortic Aneurysm

Keywords

3D printingpre-operative planningthoracic aorta aneurysmabdominal aorta aneurysm

Outcome Measures

Primary Outcomes (1)

  • surgical time

    the duration of the surgical procedure

    immediately after the surgical procedure

Study Arms (2)

historical control group

ACTIVE COMPARATOR

conventional preoperative assessment

Other: historical control

3D printed lesion model group

EXPERIMENTAL

using 3D printed lesion models for preoperative planning

Other: 3D printed lesion model

Interventions

historical controlOTHER

Received a conventional preoperative assessment

historical control group
3D printed lesion modelOTHER

Received 3D printed lesion models for preoperative planning

3D printed lesion model group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with thoracic or abdominal aortic aneurysm
  • Signed surgical consent
  • Non-emergent surgery
  • Had 2D CT imaging within the last 6 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Aortic AneurysmAortic Aneurysm, ThoracicAortic Aneurysm, Abdominal

Interventions

Historically Controlled Study

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, PhD

CONTACT

+886905301879C00152@mail.fjuh.fju.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 27, 2023

Study Start

April 8, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)