Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks

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..

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Procedure: Type II endoleak treatment

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• France
  • Dijon Cedex, France, 21079
    • Cardiovascular and thoracic surgery unit, CHU Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• All patients treated for type II endoleaks by endovascular therapy

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Type II endoleak endovascular treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence rate of type II endoleaks treated with endovascular intervention	12 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Type of type II endoleaks treatment	12 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon
• Investigators: Principal Investigator: Eric STEINMETZ, MD, Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 26, 2020
• Study Completion (Actual): May 26, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Aortic Diseases; Postoperative Hemorrhage; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Endoleak
• Other Study ID Numbers: CCVT - type 2 endoleaks

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No