NCT05575570

Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 shrinkage/diameter 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.

Conditions

• Abdominal Aortic Aneurysm Without Rupture

Interventions

Type	Name	Description
DEVICE	EVAR	EVAR stent graft and embolization material CE marked.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2022-10-12
• Last updated: 2024-04-10