Fusion Imaging for EVAR With Mobile C-arm

Completed

• Conditions: Fusion Imaging for EVAR
• Interventions: Other: Fusion imaging

• Registration Number: NCT04008212
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-07-19
• Study Completion: 2018-02-02
• Status Verified: 2019-07
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Last Update Submitted: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stenosis	Fusion imaging	-
EVAR aneurysm	Fusion imaging	-

Primary Outcome Measures

Name	Time	Method
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