NCT01526811

Brief Summary

The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

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

First Submitted

Initial submission to the registry

January 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

6.8 years

First QC Date

January 27, 2012

Last Update Submit

October 27, 2021

Conditions

AneurysmAortic AneurysmAortic Aneurysm, AbdominalVascular DiseasesCardiovascular DiseasesAortic Diseases

Keywords

EndurantStent GraftAbdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (7)

  • All-cause mortality

    through 5 years

  • Aneurysm diameter's change

    through 5 years

  • Stent graft endoleaks (type I, II and III)

    through 5 years

  • Stent Graft migration

    through 5 years

  • Conversion to open surgical repair

    through 5 years

  • Surgical or endovascular secondary procedures

    through 5 years

  • Aneurysm-related mortality

    through 5 years

Study Arms (1)

AAA patients

Subjects presenting with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment with Endurant™ Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this non-interventional study

Device: Endurant Stent graft

Interventions

Endurant Stent graftDEVICE

Endurant Stent graft implantation

Also known as: EVAR
AAA patients

Eligibility Criteria

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

Subjects diagnosed with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment

You may qualify if:

  • Patient with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release.
  • Any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm.
  • Patient not opposed to the collection and release of his/her personal information
  • Intention of physician to implant electively the Endurant™ Stent Graft System

You may not qualify if:

  • Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Centre Hospitalier d'Avignon

Avignon, 84902, France

Location

CHU de Besancon, Hôpital Jean Minjoz

Besançon, 25030, France

Location

Médipôle de Savoie

Challes-les-Eaux, 73190, France

Location

Hôpital Privé Sainte Marie

Chalon-sur-Saône, 71100, France

Location

Groupe Hospitalier Henri-Mondor

Créteil, 94010, France

Location

Clinique Claude Bernard

Ermont, 95120, France

Location

Clinique du Mousseau

Évry, 91035, France

Location

Clinique de la Présentation

Fleury-les-Aubrais, 45404, France

Location

CHU Limoges

Limoges, 87042, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Hôpital Paul Desbief

Marseille, 13002, France

Location

Hôpital Ambroise Paré

Marseille, 13006, France

Location

Hôpital Saint Joseph

Marseille, 13008, France

Location

Clinique du Millenaire

Montpellier, 34960, France

Location

CHU Nice, Hôpital Saint-Roch

Nice, 06006, France

Location

Polyclinique Quimper Sud

Quimper, 29000, France

Location

Clinique Belledonne

Saint-Martin-d'Hères, 38400, France

Location

CHl Toulon - La Seyne sur Mer

Toulon, 83056, France

Location

Clinique Sarrus Teinturiers

Toulouse, 31300, France

Location

Clinique Saint Joseph

Trélazé, 49800, France

Location

MeSH Terms

Conditions

AneurysmAortic AneurysmAortic Aneurysm, AbdominalVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Jean-Pierre Becquemin, MD, PhD

    Groupe Hospitalier Henri-Mondor, Créteil, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 6, 2012

Study Start

March 1, 2012

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

FR(20)