Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT04008212
Status:
None
Last Update Posted:
2019-07-05 00:00:00
First Post:
2019-07-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fusion Imaging for EVAR With Mobile C-arm
Sponsor:
None
Organization:
Study Overview
Official Title:
Feasibility of Computer-assisted Aortic and Iliac Endovascular Procedures With Mobile C-arm
Status:
None
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUTUR
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: