Evaluation of the Long Term Efficacy of Endovascular Trea... | NCT04409717

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

NCT04409717

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Jun 1, 2020Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Abdominal Aortic Aneurysm

Interventions

Type II endoleak treatment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

May 26, 2020Actual

Completion Date

May 26, 2020Actual

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 29, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2020

Last Update Posted Date

Jun 1, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eric STEINMETZ, Professor, Centre Hospitalier Universitaire DijonPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire DijonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Type II endoleak treatment	Procedure	Type II endoleak endovascular treatment	Patients treated for type II endoleaks

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients treated for type II endoleaks by endovascular therapy

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric STEINMETZ, MD	Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular and thoracic surgery unit, CHU Dijon		Dijon		21079	France

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided