Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05575570

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm Without Rupture	Device: EVAR	N/A

Detailed Description

In all 100 patients will be included, 50 in each group. i The first group with pre-emptive AAA sac embolization during EVAR and the control group consisted of 50 patients without pre-emptive AAA sac embolization and EVAR.

The primary goal is to investigate if the pre-emptive embolization can reduce the endoleak incidence and AAA shrinkage. Further, to investigate all 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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pre-emptive AAA sac embolization	Device: EVAR EVAR stent graft and embolization material CE marked.
Sham Comparator: No pre-emtive AAA sac embolization	Device: EVAR EVAR stent graft and embolization material CE marked.

Arm

Intervention/Treatment

Active Comparator: Pre-emptive AAA sac embolization

Device: EVAR

EVAR stent graft and embolization material CE marked.

Sham Comparator: No pre-emtive AAA sac embolization

Device: EVAR

EVAR stent graft and embolization material CE marked.

Outcome Measures

Primary Outcome Measures

Endoleak type 2 incidence, on control CT and ultrasound scanning. Further aneurysm sac regression [3 years]
Incidence of endoleak type 2 and other endoleak will be noted and analysed. Sac regression comparing the baseline CT aorta scanning and AAA diameter in mm, with control CT or ultrasound scanning.
AAA diameter, measurement on control and/or ultrasound [3 years]

Secondary Outcome Measures

Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc) [3 years]
The type of secondary interventions, incidence, time to secondary intervention, and the outcome will be recorded and analysed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stevo Duvnjak, Principal investigator, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT05575570

Other Study ID Numbers:

H-22000209

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 12, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Stevo Duvnjak, Principal investigator, Rigshospitalet, Denmark

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Aortic Aneurysm, Abdominal

Rupture

Study Results

No Results Posted as of Oct 12, 2022