Open Versus Endovascular Repair of Abdominal Aortic Aneurysms

Sponsor
Hospital Sao Joao (Other)
Overall Status
Completed
CT.gov ID
NCT04068714
Collaborator
(none)
125
1
11
11.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Type of aneurysm repair

Study Design

Study Type:
Observational
Actual Enrollment :
125 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Cohort Study of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Major adverse cardiovascular events (MACE) [12 months]

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

Secondary Outcome Measures

  1. Death [12 months]

    Death of any cause

  2. Medical complications [30 days]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Hospitalar Universitário de São João Porto Portugal 4200-061

Sponsors and Collaborators

  • Hospital Sao Joao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marina Felicidade Dias Neto, Principal Investigator, Hospital Sao Joao
ClinicalTrials.gov Identifier:
NCT04068714
Other Study ID Numbers:
  • AAArepair
First Posted:
Aug 28, 2019
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2019