Secondary Intervention and Surveillance After EVAR

Completed

• Conditions: Abdominal Aortic Aneurysm Without Rupture
• Interventions: Procedure: EVAR

• Registration Number: NCT05335642
• Lead Sponsor: Hospital Sao Joao

Brief Summary

This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution. Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded. The primary outcomes were freedom from secondary intervention and compliance with follow-up, defined as surveillance imaging performed within a periodicity no longer than 18 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30
• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-18
• Last Update Submitted: 2022-04-18
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution.

Exclusion Criteria

• Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients that had secondary interventions after EVAR	EVAR	-
Patients without secondary interventions after EVAR	EVAR	-

Primary Outcome Measures

Name	Time	Method
Number of participant with secondary intervention (SI) after EVAR	5 years follow up	SI included: access-related SI included suture of access bleeds, distal thrombo-embolectomy, patch angioplasty, or thromboendarterectomy of the common femoral artery; limb graft occlusion was defined as a thrombotic obstruction of blood flow in one or both endograft limbs, being a potential threat to the limb; lower limb ischemia was considered when there was a decrease in arterial perfusion of the limb, that was not related with limb graft occlusion; endoleak; stent migration was reported if no simultaneous type 1 endoleak was observed.

Secondary Outcome Measures

Name	Time	Method
Number of participant with compliance with follow-up after EVAR	5 years follow up	Non-compliance with surveillance was defined by an 18 months period in which no surveillance imaging was performed.

Trial Locations

Locations (1)

Marina Felicidade Dias Neto; 🇵🇹 Porto, State/Province, Portugal