Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System

Conditions
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Vascular Diseases

Intervention / Treatment
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* Device: Surgical repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: None Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Surgical repair|Open surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality rate | 1 year | 
| Mortality | Mortality rate | 3 year | 
| Morbidity | Morbidity rate | 1 year | 
| Morbidity | Morbidity rate | 3 year | 
| Endoleak type Ib | Rate of endoleak type Ib | 1 year | 
| Endoleak type Ib | Rate of endoleak type Ib | 3 year | 
| Endoleak type II | Rate of endoleak type II | 1 year | 
| Endoleak type II | Rate of endoleak type II | 3 year | 
| Endoleak type III | Rate of endoleak type III | 1 year | 
| Endoleak type III | Rate of endoleak type III | 3 year | 
| Endoleak type IV | Rate of endoleak type IV | 1 year | 
| Endoleak type IV | Rate of endoleak type IV | 3 year | 
| Adverse Events | Rate of adverse events | 1 year | 
| Adverse Events | Rate of adverse events | 3 year | 
| Reinterventions | Rate of reinterventions | 1 year | 
| Reinterventions | Rate of reinterventions | 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)). | 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)). | 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) | 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) | 3 year | 
| Partially thrombosed false lumen (dissections) | Rate of patients with partially thrombosed false lumen in the stented area | 1 year | 
| Partially thrombosed false lumen (dissections) | Rate of patients with partially thrombosed false lumen in the stented area | 3 year | 
| Patent false lumen (dissections) | Rate of patients with patent false lumen in the stented area | 1 year | 
| Patent false lumen (dissections) | Rate of patients with patent false lumen in the stented area | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic aneurysms, aortic dissections, thoracic