Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT01526811
Study type Observational
Source Medtronic Endovascular
Status Completed
Start date March 2012
Completion date December 21, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Recruiting NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Recruiting NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Recruiting NCT02543996 - Human Biospecimen Procurement Protocol: Biorepository to Support Translational Research to Identify Disease Mechanism(s)
Active, not recruiting NCT03603769 - In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids N/A
Not yet recruiting NCT03575650 - Early Detection of Imaging-derived Subclinical Cardiac Injuries
Recruiting NCT03534908 - Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
Completed NCT03807323 - Tools for Lasting Lifestyle Changes N/A
Enrolling by invitation NCT03271931 - Active Choice in the EHR to Promote Statin Therapy N/A
Recruiting NCT03413345 - Effect of Rehabilitation on Ejection Fraction (FE) in Cardiopathic and Non Cardiopathic Patients Undergoing Major Orthopedic Surgery N/A
Recruiting NCT03699293 - NSAIDs vs. Coxibs in the Presence of Aspirin Phase 4
Active, not recruiting NCT03292029 - Pilot Medical Evaluation of the T50 Test N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Safety and Efficacy of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Not yet recruiting NCT03659565 - Increasing Caregiver and Patient Engagement Through PHR Use N/A
Recruiting NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Active, not recruiting NCT02797392 - Feasibility of a Preventive Program Against Lifestyle Related Diseases N/A
Completed NCT02986165 - Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation N/A