Secondary Intervention and Surveillance After EVAR

NCT05335642 | Completed FDA Device

• 1 other identifier: 10353
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participant with compliance with follow-up after EVAR

  5 years follow up

Study Arms (2)

Patients that had secondary interventions after EVAR

Procedure: EVAR

Patients without secondary interventions after EVAR

Procedure: EVAR

Interventions

EVAR PROCEDURE

Endovascular repair of abdominal aortic aneurysms

Patients that had secondary interventions after EVAR; Patients without secondary interventions after EVAR

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients submitted to elective EVAR in a university center.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sao Joao: lead

Study Sites (1)

Marina Felicidade Dias Neto

Porto, State/Province, 4200, Portugal

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: June 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

PT (1)