NCT05647486

Brief Summary

This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

4.7 years

First QC Date

November 22, 2022

Last Update Submit

December 7, 2022

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (4)

  • Number of patients with major adverse cardiovascular events

    Number of participants with major adverse cardiovascular events

    30rd day post-operatively

  • Number of patients with acute kidney injury

    Number of participants with acute kidney injury according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria

    30rd day post-operatively

  • Number of patients with post-implantation syndrome

    Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection

    30rd day post-operatively

  • Deaths of any cause

    Number of participants who died from any cause

    30rd day post-operatively

Study Arms (1)

EVAR

Patients with AAA, treated electively by EVAR. The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed.

Other: 30-day postoperative outcome

Interventions

30-day postoperative outcomeOTHER

The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed

EVAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included consecutive AAA patients treated electively by EVAR

You may qualify if:

  • Only patients managed with EVAR using standard bifurcated devices in elective setting were included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eleni Arnaoutoglou, Professor

    University of Thessaly

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 12, 2022

Study Start

March 23, 2016

Primary Completion

December 1, 2020

Study Completion

January 13, 2021

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)