Clinical Trials Directory

Trials / Completed

CompletedNCT04008212

Fusion Imaging for EVAR With Mobile C-arm

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

Status
Completed
Phase
Study type
Observational
Enrollment
59 (actual)
Sponsor
Rennes University Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2016-01-01
Primary completion
2016-07-19
Completion
2018-02-02
First posted
2019-07-05
Last updated
2019-07-05

Source: ClinicalTrials.gov record NCT04008212. Inclusion in this directory is not an endorsement.