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OpenTrials
Completed

NCT Number: NCT05335642

Secondary Intervention and Surveillance After EVAR

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Without Rupture

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marina Felicidade Dias Neto

Porto, State/Province, 4200, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVAR

Procedure

Endovascular repair of abdominal aortic aneurysms

Primary outcomes

  1. Number of participant with secondary intervention (SI) after EVAR

    Time frame: 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 outcomes

  1. Number of participant with compliance with follow-up after EVAR

    Time frame: 5 years follow up

    Non-compliance with surveillance was defined by an 18 months period in which no surveillance imaging was performed.

Sponsors and collaborators

Lead sponsor

Hospital Sao Joao

Other

Registry information

Official study title

Secondary Intervention and Surveillance After Abdominal Aortic Aneurysm Endovascular Repair: Retrospective Cohort Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2022
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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