Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France
FEOR
Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System
1 other identifier
observational
100
1 country
2
Brief Summary
The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France. This registry is a requirement of the Haute Autorité de Santé (HAS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedJanuary 25, 2023
January 1, 2023
4 months
August 14, 2019
January 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoint
The primary endpoint is a composite endpoint of morbi-mortality defined as following: * Mortality rate * Morbidity rate including neurological complications, visceral malperfusion, and renal complications. Neurological complications comprise new cerebrovascular accident (CVA)/stroke, spinal cord ischemia, paraparesis, paraplegia as reported in the eCRF. Visceral malperfusion includes new bowel obstruction and visceral ischemia/infarction as reported in the eCRF. Renal complications comprise new renal insufficiency and renal insufficiency requiring dialysis as reported in the eCRF.
30 days
Secondary Outcomes (24)
Mortality
1 year
Mortality
3 year
Morbidity
1 year
Morbidity
3 year
Endoleak type Ib
1 year
- +19 more secondary outcomes
Interventions
Eligibility Criteria
Male and female patients with aortic pathologies who have undergone implantation of the E-vita OPEN PLUS Stent Graft System at their physician's discretion since July 15th, 2014.
You may qualify if:
- None
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JOTEC GmbHlead
Study Sites (2)
Rennes Pontchaillou University Medical Centre
Rennes, Cedex 9, 35033, France
Clinique de l'Infirmerie Protestante à Lyon
Caluire-et-Cuire, 69300, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe Verhoye, Prof.
Rennes Pontchaillou University Medical Centre
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2019
First Posted
August 15, 2019
Study Start
November 1, 2019
Primary Completion
February 20, 2020
Study Completion
September 30, 2022
Last Updated
January 25, 2023
Record last verified: 2023-01