Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

NCT04068714 | Completed

• 1 other identifier: AAArepair
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational retrospective cohort study of all patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary referral centre between 2009 and 2015. Patients were excluded if they were non-elective cases or had complex aortic aneurysms (juxta-renal, thoraco-abdominal or thoracic). Differences between both groups of repair were assessed, as well as short- and long-term complications including medical complications, duration of hospital stay, major cardiovascular events, mortality and vascular reintervention.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  Acute myocardial infarction (with PCI, CABG or no intervention), decompensated heart failure, neurological deficit (including transient ischemic attack or stroke) or death

  12 months

Secondary Outcomes (2)

• Death

  12 months

• Medical complications

  30 days

Study Arms (2)

Endovascular repair

Observational retrospective cohort of patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015 through endovascular repair. The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.

Procedure: Type of aneurysm repair

Open repair

Observational retrospective cohort of patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015 through open repair. The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.

Procedure: Type of aneurysm repair

Interventions

Type of aneurysm repair PROCEDURE

In open surgery repair group, aneurysm repair was performed by open surgery including aortobifemoral bypass, aorto-bi-iliac bypass and tubular aortic bypass. In endovascular repair (EVAR group), aneurysm correction was performed by percutaneous approach, femoral cutdowns and aorto-uni-iliac EVARs with femorofemoral bypass.

Endovascular repair; Open repair

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational retrospective cohort study of all patients consecutively submitted to elective AAA surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015. The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.

You may qualify if:

• This is an observational retrospective cohort study of all patients consecutively submitted to elective AAA surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015.

Sponsors & Collaborators

• Hospital Sao Joao: lead

Study Sites (1)

Centro Hospitalar Universitário de São João

Porto, 4200-061, 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: August 20, 2019
• First Posted: August 28, 2019
• Study Start: January 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)