Fusion Imaging for EVAR With Mobile C-arm

Feasibility of Computer-assisted Aortic and Iliac Endovascular Procedures With Mobile C-arm

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04008212

Acronym

FUTUR

Enrollment

Registered

2019-07-05

Start date

2016-01-01

Completion date

2018-02-02

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fusion Imaging for EVAR

Brief summary

Fusion imaging is a technique that facilitates endovascular navigation but is only available in hybrid rooms. The goal of this study is to evaluate the feasibility of fusion imaging with a mobile C-arm in a conventional operating room through the use of an angio-navigation station.

Detailed description

The study include all patients who underwent an aortic stent graft procedure in a conventional operating room with a mobile flat-panel detector (Cios Alpha, Siemens) connected to an angio-navigation station (EndoNaut, Therenva). The intention is to perform preoperative 3D CT/perioperative 2D fluoroscopy fusion Imaging using an automatic registration process. Registration is considered successful when the software was able to correctly overlay preoperative 3D vascular structures onto the fluoroscopy image. For EVAR, contrast dose, operation and fluoroscopy time were compared to those of a control group drawn from the department's database who underwent a procedure with a C-arm image intensifier.

Interventions

OTHERFusion imaging

Fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Patients eligible for endovascular treatment of aneurysm disease of the aorta. Procedure performed in a conventional operating room equipped with a mobile flat-panel detector (30´30 cm) (Cios-Alpha, Siemens®, Munich, Germany) and a floating table. Patients who received written and verbal information about the protocol and did not object to participating in the trial.

Exclusion criteria

Patients who also required a conventional surgical revascularisation procedure or who required an endovascular revascularisation procedure in another site. Patients who underwent MR angiography during preoperative evaluation. Non-analysable CT angiogram (no or poor injection). Procedure performed in a hybrid room or in an operating room not equipped with a mobile flat-panel detector.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of fusion imaging	6 months	To evaluate the feasibility of fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026