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).
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.
Study Type
OBSERVATIONAL
Enrollment
100
Open surgery
Rennes Pontchaillou University Medical Centre
Rennes, Cedex 9, France
Clinique de l'Infirmerie Protestante à Lyon
Caluire-et-Cuire, France
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.
Time frame: 30 days
Mortality
Mortality rate
Time frame: 1 year
Mortality
Mortality rate
Time frame: 3 year
Morbidity
Morbidity rate
Time frame: 1 year
Morbidity
Morbidity rate
Time frame: 3 year
Endoleak type Ib
Rate of endoleak type Ib
Time frame: 1 year
Endoleak type Ib
Rate of endoleak type Ib
Time frame: 3 year
Endoleak type II
Rate of endoleak type II
Time frame: 1 year
Endoleak type II
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Rate of endoleak type II
Time frame: 3 year
Endoleak type III
Rate of endoleak type III
Time frame: 1 year
Endoleak type III
Rate of endoleak type III
Time frame: 3 year
Endoleak type IV
Rate of endoleak type IV
Time frame: 1 year
Endoleak type IV
Rate of endoleak type IV
Time frame: 3 year
Adverse Events
Rate of adverse events
Time frame: 1 year
Adverse Events
Rate of adverse events
Time frame: 3 year
Reinterventions
Rate of reinterventions
Time frame: 1 year
Reinterventions
Rate of reinterventions
Time frame: 3 year
Secondary interventions
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)).
Time frame: 1 year
Secondary interventions
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)).
Time frame: 3 year
Fully thrombosed false lumen (dissections)
Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft)
Time frame: 1 year
Fully thrombosed false lumen (dissections)
Rate of patients with fully thrombosed false lumen in the stented area (until 2cm proximal from distal end of stent graft)
Time frame: 3 year
Partially thrombosed false lumen (dissections)
Rate of patients with partially thrombosed false lumen in the stented area
Time frame: 1 year
Partially thrombosed false lumen (dissections)
Rate of patients with partially thrombosed false lumen in the stented area
Time frame: 3 year
Patent false lumen (dissections)
Rate of patients with patent false lumen in the stented area
Time frame: 1 year
Patent false lumen (dissections)
Rate of patients with patent false lumen in the stented area
Time frame: 3 year