Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

Abdominal Aortic Aneurysm Without Rupture Clinical Trial

Official title:

Retrospective Cohort Study of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068714
• Other study ID #: AAArepair
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2019
• Source: Hospital Sao Joao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Type of aneurysm repair
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.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário de São João	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death	Death of any cause	12 months
Secondary	Medical complications	Including digestive complications such as intestinal obstruction or ischemia, acute myocardial infarction (with PCI, CABG or no intervention), decompensated heart failure, neurological deficit (including transient ischemic attack or stroke), respiratory failure (including pneumonia, prolongation of endotracheal intubation, need for a tracheostomy) or acute renal failure (plasma creatinine > 3 mg/dL with or without the need for dialysis).	30 days