Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05575570
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2022-10-04
Brief Title:
Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study
Detailed Description:
In all 124 patients will be included 62 in each group
The first group 62 patients with pre-emptive AAA sac embolization during EVAR and the control group consisted of 62 patients without pre-emptive AAA sac embolization
The primary goal is to investigate AAA shrinkagediameter changes in the pre-emptive embolization group compared with the non-embolization group Further to investigate all endoleaks and secondary interventions during the follow-up and any difference between groups and correlation if any with pre-emptive embolization
Demographic comorbidities antiplatelet and anticoagulation drugs AAA characteristics patent lumbal and inferior mesenteric artery intervention characteristics and follow-up data will be recorded and analysed
The first group 62 patients with pre-emptive AAA sac embolization during EVAR and the control group consisted of 62 patients without pre-emptive AAA sac embolization
The primary goal is to investigate AAA shrinkagediameter changes in the pre-emptive embolization group compared with the non-embolization group Further to investigate all endoleaks and secondary interventions during the follow-up and any difference between groups and correlation if any with pre-emptive embolization
Demographic comorbidities antiplatelet and anticoagulation drugs AAA characteristics patent lumbal and inferior mesenteric artery intervention characteristics and follow-up data will be recorded and analysed
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?:
False
Is an FDA AA801 Violation?:
None