Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Abdominal Aortic Aneurysm Without Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05575570
• Other study ID #: H-22000209
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm Without Rupture
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Rupture

Intervention

Device:
• EVAR
EVAR stent graft and embolization material CE marked.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AAA diameter and volume changes/sac regression during follow-up, measurement on control CT and/or ultrasound after EVAR.	Sac regression uses the centerline reconstruction to compare the baseline CT aorta scanning and AAA diameter measurement - maximal AAA diameter in millimetres (mm).; Further, total volume measurement in (ml) of AAA and sac changes during the follow-up comparing the index CT scan with control CT or ultrasound scanning.	5 years
Primary	AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program	Automatic software measured the maximal AAA diameter in millimetres (mm) on index CT and follow-up control scanning. The same technique and measurement points will be used. Specialised software dedicated to AAA maximal diameter will be used.; Automatic software measurement of total volume of AAA in millilitres (ml) on index CT scanning and on control CT scanning. Specialised software will perform measurement and volumetry expressed in millilitres (ml).	3 years
Secondary	Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc)	The type of secondary interventions, incidence, time to secondary intervention, and the outcome will be recorded and analysed.	5 years
Secondary	Endoleak type 2 incidence, on control CT and ultrasound scanning	Incidence of endoleak type 2 and other endoleak will be noted and analysed.	5 years