Vascular DiseasesFEORNCT04058691
Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France
An observational study of Vascular Diseases, run by JOTEC GmbH at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Surgical repair
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Nov 2019to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- None
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique de l'Infirmerie Protestante à Lyon
Caluire-et-Cuire, 69300
Rennes Pontchaillou University Medical Centre
Rennes, Cedex 9, 35033
About this study
Official title: Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System
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).
Read the 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.
- Conditions
- Vascular Diseases
- Being tested
- Surgical repair
- Keywords
- Aortic aneurysms, aortic dissections, thoracic
- Medical subject headings
- Vascular Diseases, Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical repairDevice
Also called Frozen Elephant Trunk Technique
Open surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (24)
Mortality
Mortality rate
Measured: 1 year
Mortality
Mortality rate
Measured: 3 year
Morbidity
Morbidity rate
Measured: 1 year
Morbidity
Morbidity rate
Measured: 3 year
Endoleak type Ib
Rate of endoleak type Ib
Measured: 1 year
Endoleak type Ib
Rate of endoleak type Ib
Measured: 3 year
Endoleak type II
Rate of endoleak type II
Measured: 1 year
Endoleak type II
Rate of endoleak type II
Measured: 3 year
Endoleak type III
Rate of endoleak type III
Measured: 1 year
Endoleak type III
Rate of endoleak type III
Measured: 3 year
Endoleak type IV
Rate of endoleak type IV
Measured: 1 year
Endoleak type IV
Rate of endoleak type IV
Measured: 3 year
Adverse Events
Rate of adverse events
Measured: 1 year
Adverse Events
Rate of adverse events
Measured: 3 year
Reinterventions
Rate of reinterventions
Measured: 1 year
Reinterventions
Rate of reinterventions
Measured: 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)).
Measured: 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)).
Measured: 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)
Measured: 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)
Measured: 3 year
Partially thrombosed false lumen (dissections)
Rate of patients with partially thrombosed false lumen in the stented area
Measured: 1 year
Partially thrombosed false lumen (dissections)
Rate of patients with partially thrombosed false lumen in the stented area
Measured: 3 year
Patent false lumen (dissections)
Rate of patients with patent false lumen in the stented area
Measured: 1 year
Patent false lumen (dissections)
Rate of patients with patent false lumen in the stented area
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Nov 2019
- Primary completion20 Feb 2020
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Verhoye, Prof., Principal investigator, Rennes Pontchaillou University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058691
- Sponsor's protocol ID
- FEOR
- Acronym
- FEOR
- Status last verified
- Jan 2023
- First submitted
- 14 Aug 2019
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System
- ClinicalTrials.gov ID
- NCT04058691
- Acronym / sponsor ID
- FEOR / FEOR
- Conditions
- Vascular Diseases
- Keywords
- Aortic aneurysms, aortic dissections, thoracic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical repairAlso: Frozen Elephant Trunk TechniqueOpen surgery | Device | – |
Primary outcome
Primary endpoint
Time frame: 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.
24 secondary outcomes
Mortality
Time frame: 1 year
Mortality
Time frame: 3 year
Morbidity
Time frame: 1 year
Morbidity
Time frame: 3 year
Endoleak type Ib
Time frame: 1 year
Endoleak type Ib
Time frame: 3 year
Endoleak type II
Time frame: 1 year
Endoleak type II
Time frame: 3 year
Endoleak type III
Time frame: 1 year
Endoleak type III
Time frame: 3 year
Endoleak type IV
Time frame: 1 year
Endoleak type IV
Time frame: 3 year
Adverse Events
Time frame: 1 year
Adverse Events
Time frame: 3 year
Reinterventions
Time frame: 1 year
Reinterventions
Time frame: 3 year
Secondary interventions
Time frame: 1 year
Secondary interventions
Time frame: 3 year
Fully thrombosed false lumen (dissections)
Time frame: 1 year
Fully thrombosed false lumen (dissections)
Time frame: 3 year
Partially thrombosed false lumen (dissections)
Time frame: 1 year
Partially thrombosed false lumen (dissections)
Time frame: 3 year
Patent false lumen (dissections)
Time frame: 1 year
Patent false lumen (dissections)
Time frame: 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Verhoye, Prof. principal investigator
Rennes Pontchaillou University Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases, run by JOTEC GmbH at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.