Secondary Intervention and Surveillance After EVAR

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm Without Rupture
• Intervention / Treatment: Procedure: EVAR

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• Portugal
  • State/Province
    • Porto, State/Province, Portugal, 4200
      • Marina Felicidade Dias Neto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients submitted to elective EVAR in a university center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients that had secondary interventions after EVAR	Procedure: EVAR; Endovascular repair of abdominal aortic aneurysms
Patients without secondary interventions after EVAR	Procedure: EVAR; Endovascular repair of abdominal aortic aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Sao Joao

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Aortic Diseases; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 10353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes