Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05665101
Status:
RECRUITING
Last Update Posted:
2023-05-12
First Post:
2022-12-07
Brief Title:
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks the EVAR-SE Study
Sponsor:
Univ-Prof Dr med Hans-Henning Eckstein
Organization:
Technical University of Munich
Study Overview
Official Title:
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks the EVAR-SE Study- A Randomized Controlled Multicentre Study in Germany
Status:
RECRUITING
Status Verified Date:
2023-05
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:
EVAR-SE
Brief Summary:
Beyond a certain threshold diameter Abdominal aortic aneurysms AAA are treated by open surgical repair or more often by endovascular aortic aneurysm repair EVAR The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit Small vessels supplying parts of the bowel or the spine are regularly covered In a quarter of patients this may result in an inversion of blood flow in the mentioned vessels leading to persistent blood flow within the AAA referred to as type II endoleak T2EL Occurrence of T2EL is associated with complications like AAA growth or even rupture
Secondary interventions to treat T2EL often fail and may be highly invasive Various risk factors for T2EL have been described This enables prediction whether a patient is at high risk for T2EL after EVAR Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2ELThe present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL
Secondary interventions to treat T2EL often fail and may be highly invasive Various risk factors for T2EL have been described This enables prediction whether a patient is at high risk for T2EL after EVAR Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2ELThe present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01KG2128 | OTHER_GRANT | Bundesministerium für Bildung und Forschung | None |