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Fusion Imaging for EVAR With Mobile C-arm (FUTUR)

R

Rennes University Hospital

Status

Completed

Conditions

Fusion Imaging for EVAR

Treatments

Other: Fusion imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04008212
35RC15_3020

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Volunteers

No 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.

Trial design

59 participants in 2 patient groups

EVAR aneurysm
Treatment:
Other: Fusion imaging
Stenosis
Treatment:
Other: Fusion imaging

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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