Vascular Diseases
Conditions
Keywords
Aortic aneurysms, aortic dissections, thoracic
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).
Detailed description
Data Collection on patients who have been implanted with an E-vita OPEN PLUS Stent Graft System from 15th July 2014 until 31st May 2019. The E-vita OPEN PLUS Stent Graft System was implanted at the discretion of the treating physician. Participating physicians provided their observations collected during routine care for patients he/she had decided to treat with the E-vita OPEN PLUS Stent Graft System. The period of data collection was three years starting from the intervention of each patient. Data verification was performed.
Interventions
DEVICESurgical repair
Open surgery
Sponsors
JOTEC GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
None
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | Mortality rate |
| Morbidity | 1 year | Morbidity rate |
| Endoleak type Ib | 1 year | Rate of endoleak type Ib |
| Endoleak type II | 1 year | Rate of endoleak type II |
| Endoleak type III | 1 year | Rate of endoleak type III |
| Patent false lumen (dissections) | 1 year | Rate of patients with patent false lumen in the stented area |
| Adverse Events | 1 year | Rate of adverse events |
| Reinterventions | 1 year | Rate of reinterventions |
| Secondary interventions | 1 year | Rate of secondary interventions: TAA: A planned additional endovascular intervention with a TAA stent graft in the downstream aorta. Treatment of the dissection distally to the targeted pathology that was initially treated using the Evita OPEN PLUS Stent Graft is not a reintervention but an additional intervention (secondary intervention (s)). |
| Fully thrombosed false lumen (dissections) | 1 year | Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft) |
| Partially thrombosed false lumen (dissections) | 1 year | Rate of patients with partially thrombosed false lumen in the stented area |
| Endoleak type IV | 1 year | Rate of endoleak type IV |
Countries
France
Outcome results
None listed