NCT04409717

Brief Summary

Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 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

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 26, 2020

Last Update Submit

May 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of type II endoleaks treated with endovascular intervention

    12 years

Secondary Outcomes (1)

  • Type of type II endoleaks treatment

    12 years

Study Arms (1)

Patients treated for type II endoleaks

Patients treated for type II endoleaks between the 01 January 2008 and the 31 March 2018 in the Cardiovascular and Thoracic Surgery Unit of Dijon Burgundy University Hospital

Procedure: Type II endoleak treatment

Interventions

Type II endoleak endovascular treatment

Patients treated for type II endoleaks

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated for type II endoleaks by endovascular therapy between the 01 January 2008 and the 31 December 2018

You may qualify if:

  • All patients treated for type II endoleaks by endovascular therapy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular and thoracic surgery unit, CHU Dijon

Dijon, 21079, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Eric STEINMETZ, MD

    Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 1, 2020

Study Start

January 1, 2020

Primary Completion

May 26, 2020

Study Completion

May 26, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.

Locations