FEOR: Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
In this registry data will be collected on patients who have been implanted with an E-vita OPEN PLUS Stent Graft System from 15th of July 2014 until May 31st 2019. The E-vita OPEN PLUS Stent Graft System will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-vita OPEN PLUS Stent Graft System. As this registry is a requirement of the Haute Autorité de Santé (HAS), written Informed consent of the patients is not required, however all patients will be provided with a non-objection letter and given the opportunity to refuse to participate.
The period of data collection will be three years starting from the intervention of each patient. Data verification will be performed.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Mortality [1 year]
Mortality rate
- Mortality [3 year]
Mortality rate
- Morbidity [1 year]
Morbidity rate
- Morbidity [3 year]
Morbidity rate
- Endoleak type Ib [1 year]
Rate of endoleak type Ib
- Endoleak type Ib [3 year]
Rate of endoleak type Ib
- Endoleak type II [1 year]
Rate of endoleak type II
- Endoleak type II [3 year]
Rate of endoleak type II
- Endoleak type III [1 year]
Rate of endoleak type III
- Endoleak type III [3 year]
Rate of endoleak type III
- Endoleak type IV [1 year]
Rate of endoleak type IV
- Endoleak type IV [3 year]
Rate of endoleak type IV
- Adverse Events [1 year]
Rate of adverse events
- Adverse Events [3 year]
Rate of adverse events
- Reinterventions [1 year]
Rate of reinterventions
- Reinterventions [3 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)).
- Secondary interventions [3 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)
- Fully thrombosed false lumen (dissections) [3 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
- Partially thrombosed false lumen (dissections) [3 year]
Rate of patients with partially thrombosed false lumen in the stented area
- Patent false lumen (dissections) [1 year]
Rate of patients with patent false lumen in the stented area
- Patent false lumen (dissections) [3 year]
Rate of patients with patent false lumen in the stented area
Eligibility Criteria
Criteria
Inclusion Criteria:
None
Exclusion Criteria:
None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rennes Pontchaillou University Medical Centre | Rennes | Cedex 9 | France | 35033 |
| 2 | Clinique de l'Infirmerie Protestante à Lyon | Caluire et Cuire | France | 69300 |
Sponsors and Collaborators
- JOTEC GmbH
Investigators
- Principal Investigator: Jean-Philippe Verhoye, Prof., Rennes Pontchaillou University Medical Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FEOR