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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical repair | Device | Open surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | The primary endpoint is a composite endpoint of morbi-mortality defined as following:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality rate | 1 year |
| Mortality | Mortality rate | 3 year |
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Inclusion Criteria:
None
Exclusion Criteria:
None
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Verhoye, Prof. | Rennes Pontchaillou University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes Pontchaillou University Medical Centre | Rennes | Cedex 9 | 35033 | France | ||
| Clinique de l'Infirmerie Protestante à Lyon |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D001014 | Aortic Aneurysm |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000783 | Aneurysm |
| D001018 | Aortic Diseases |
| D000094665 | Dissection, Blood Vessel |
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| ID | Term |
|---|---|
| D000071062 | Sutureless Surgical Procedures |
| ID | Term |
|---|---|
| D058106 | Wound Closure Techniques |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| Caluire-et-Cuire |
| 69300 |
| France |
| D000094683 |
| Acute Aortic Syndrome |