Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04592185
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-04-28
First Post:
2020-10-15
Brief Title:
The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
Sponsor:
Vascutek Ltd
Organization:
Vascutek Ltd
Study Overview
Official Title:
Post-registration Observational Study on the Custom-made Abdominal Aortic Endograft Fenestrated Anaconda
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-04
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:
EPI-EFA
Brief Summary:
The French Ministry registered the Fenestrated Anaconda on the List of Reimbursable Products and Services LPPR by the French Health Insurance on February 2018 for a duration of 5 years while taking up the conditions for carrying out the act recommended by the CNEDiMTS Committee in charge of medical device review namely the carrying out of a post-registration study for the renewal of the authorization This renewal of registration is conditioned by the set-up of a long-term follow-up study of all patients treated with the Fenestrated Anaconda in France
To do this this study will be carried out in partnership with the Federation of Medical Specialties FSM and the National Professional Council CNP of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda from the registry called Datavasc developed by the CNP and available online on the FSMs electronic platform
To do this this study will be carried out in partnership with the Federation of Medical Specialties FSM and the National Professional Council CNP of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda from the registry called Datavasc developed by the CNP and available online on the FSMs electronic platform
Detailed Description:
EPI-EFA study Post-registration study of the Fenestrated Anaconda in the management of a complex abdominal juxtarenal pararenal suprarenal aortic aneurysm whether or not associated with a distal common iliac artery or thoracoabdominal aneurysm type IV in high-risk patients requiring treatment for whom a surgical contraindication has been asked
Study type observational national multi-centre prospective non-comparative study as open registry
Primary objective To evaluate the long-term interest of Fenestrated Anaconda on all patients treated with in France The data collected should be
1-year mortality rate related to device procedure any cause primary endpoint
Stent-related adverse events endoleak migration integrity of the device renal events ischemia medullary paraplegia paraparesis intestinal secondary endpoints
Study timelines
Duration follow-up
1-year recruitment period from October 2019 with a minimum of 91 patients
Mid-term follow-up at 1 year
Routine practice until 5 years
Reports to be submitted to French Health Authority
Interim report with mid-term follow-up data for renewal dossier
Final report with long-term follow-up data
Study type observational national multi-centre prospective non-comparative study as open registry
Primary objective To evaluate the long-term interest of Fenestrated Anaconda on all patients treated with in France The data collected should be
1-year mortality rate related to device procedure any cause primary endpoint
Stent-related adverse events endoleak migration integrity of the device renal events ischemia medullary paraplegia paraparesis intestinal secondary endpoints
Study timelines
Duration follow-up
1-year recruitment period from October 2019 with a minimum of 91 patients
Mid-term follow-up at 1 year
Routine practice until 5 years
Reports to be submitted to French Health Authority
Interim report with mid-term follow-up data for renewal dossier
Final report with long-term follow-up data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None