Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Rigshospitalet

Status: Not yet enrolling

Conditions: Abdominal Aortic Aneurysm Without Rupture

Treatments: Device: EVAR

Study type: Interventional

Funder types: Other

Identifiers

NCT05575570

H-22000209

Details and patient eligibility

About

Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with 55mm (male) or 50 mm (female) AAA, available for EVAR
• > 18 year old

Exclusion criteria

• Not accept to participate
• Ruptured AAA
• Outside for instruction for the use EVAR

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

124 participants in 2 patient groups

Pre-emptive AAA sac embolization

Active Comparator group

Treatment:

Device: EVAR

No pre-emtive AAA sac embolization

Sham Comparator group

Treatment:

Device: EVAR