Secondary Intervention and Surveillance After EVAR

Abdominal Aortic Aneurysm Without Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05335642
• Other study ID #: 10353
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2022
• Source: Hospital Sao Joao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• EVAR
Endovascular repair of abdominal aortic aneurysms

Locations

Country	Name	City	State
Portugal	Marina Felicidade Dias Neto	Porto	State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participant with secondary intervention (SI) after EVAR	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.	5 years follow up
Secondary	Number of participant with compliance with follow-up after EVAR	Non-compliance with surveillance was defined by an 18 months period in which no surveillance imaging was performed.	5 years follow up