Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02018744
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2013-11-18
Brief Title:
Nellix Registry Study EVAS-Global
Sponsor:
Endologix
Organization:
Endologix
Study Overview
Official Title:
Multicenter Observational Post-Market Real World Registry to Assess Outcomes of Patients Treated With the Nellix System for Endovascular Abdominal Aortic Aneurysm Repair
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
EVAS-FORWARD 1
Brief Summary:
This registry has been designed as a multicenter single arm open label post-market registry study with consecutive eligible patient enrollment at each site All subjects undergoing the Endovascular Aneurysm Sealing System EVAS with the Nellix-System Subjects will be followed up to discharge discharge and as per institutional standard of care thereafter through to 5 years total follow-up commitment This registry of the Nellix System which has received the market authorization of the European Union Conformité Européenne CE-certification in a real world patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System
Up to 300 patients diagnosed with abdominal aortic aneurysm AAA who are considered candidates for Endovascular Repair in up to 30 international centers will be enrolled in the study
Up to 300 patients diagnosed with abdominal aortic aneurysm AAA who are considered candidates for Endovascular Repair in up to 30 international centers will be enrolled in the study
Detailed Description:
1 Baseline medical history physical exams CT image bloodwork
2 Procedure implantation information
3 Discharge Physical exam bloodwork and adverse events if any
4 Follow-up according to institutional standard through to 5 years including Physical exam CT image or standard of care imaging eg Doppler Ultrasound bloodwork and adverse events if any
2 Procedure implantation information
3 Discharge Physical exam bloodwork and adverse events if any
4 Follow-up according to institutional standard through to 5 years including Physical exam CT image or standard of care imaging eg Doppler Ultrasound bloodwork and adverse events if any
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?:
None