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Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01526811
First received: January 27, 2012
Last updated: July 10, 2014
Last verified: July 2014

January 27, 2012
July 10, 2014
March 2012
December 2018   (final data collection date for primary outcome measure)
  • All-cause mortality [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Aneurysm diameter's change [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Stent graft endoleaks (type I, II and III) [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Stent Graft migration [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Conversion to open surgical repair [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Surgical or endovascular secondary procedures [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
  • Aneurysm-related mortality [ Time Frame: through 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01526811 on ClinicalTrials.gov Archive Site
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Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

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.

Data regarding the use under routine practice of abdominal aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from July 13, 2010, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve at least 150 patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.

In France, The Endurant™ Stent Graft System is registered on the LPPR for a period of 3 years since September 13, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Endurant stent graft.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Aneurysm
  • Aortic Aneurysm
  • Aortic Aneurysm, Abdominal
  • Vascular Diseases
  • Cardiovascular Diseases
  • Aortic Diseases
Device: Endurant Stent graft
Endurant Stent graft implantation
Other Name: EVAR
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
Intervention: Device: Endurant Stent graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01526811
P#8888
No
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Jean-Pierre Becquemin, MD, PhD Groupe Hospitalier Henri-Mondor, Créteil, France
Medtronic Endovascular
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP