Aorta AneurysmNCT06187051
Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best
An observational study of Aorta Aneurysm, run by University Paul Sabatier of Toulouse.
Trial summary
Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aorta Aneurysm
- What is being tested?
- FEVAR and Explantation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Dec 2023
- 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: Patient presenting a type 1A endoleak after EVAR for AAA during the follow up
Who may be able to join
- Type 1A endoleak after EVAR
Who cannot join
- no
About this study
Official title: FEVAR or Open Repair to Treat Type 1 Endoleak : A French Multicentric Study
Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation.
A retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.
- Conditions
- Aorta Aneurysm
- Being tested
- FEVAR, Explantation
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEVARDevice
Relining the EVAR with FEVAR
ExplantationDevice
open surgery to explant the previous EVAR
| Study group | Role | What they receive |
|---|---|---|
| Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR | Not described Receives: Device: FEVAR | |
| Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR | Not described Receives: Device: Explantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative mortality
Patient death after the treatment of type 1A endoleak
Measured: day 30 post operative
Major adverse cardiovascular event (MACE) post operative
Patient presenting after surgery a composite score (MACE) including
- nonfatal stroke,
- nonfatal myocardial infarction
- cardiovascular death
Measured: day 30 post operative
Redo surgery after type 1A endoleak surgery
Reintervention after FEVAR or explantation surgery
Measured: 30 day, 6 months, 12 months, 24 months
Secondary outcomes (1)
Efficiency of the treatment
No reintervention after open surgery or Thrombosis of the aneurysmal sac after FEVAR
Measured: 30 day, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2010
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta AneurysmStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187051
- Sponsor's protocol ID
- Type 1 endoleak : FEVAR vs OSR
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEVAR or Open Repair to Treat Type 1 Endoleak : A French Multicentric Study
- ClinicalTrials.gov ID
- NCT06187051
- Acronym / sponsor ID
- Type 1 endoleak : FEVAR vs OSR
- Conditions
- Aorta Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 2 Jan 2024 (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.
Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation.
A retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR | – | Device: FEVAR |
| Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR | – | Device: Explantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient presenting a type 1A endoleak after EVAR for AAA during the follow up
Key inclusion criteria (1 listed)
- Type 1A endoleak after EVAR
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| FEVARRelining the EVAR with FEVAR | Device | Patient presenting a type 1A endoleak after EVAR treated by relining with FEVAR |
| Explantationopen surgery to explant the previous EVAR | Device | Patient presenting a type 1A endoleak after EVAR treated by explantation of the EVAR |
Primary outcome
Post operative mortality
Time frame: day 30 post operative
Patient death after the treatment of type 1A endoleak
Major adverse cardiovascular event (MACE) post operative
Time frame: day 30 post operative
Patient presenting after surgery a composite score (MACE) including * nonfatal stroke, * nonfatal myocardial infarction * cardiovascular death
Redo surgery after type 1A endoleak surgery
Time frame: 30 day, 6 months, 12 months, 24 months
Reintervention after FEVAR or explantation surgery
1 secondary outcome
Efficiency of the treatment
Time frame: 30 day, 6 months, 12 months, 24 months
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 10 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorta Aneurysm, run by University Paul Sabatier of Toulouse.
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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Post operative mortality (time frame: day 30 post operative). The study lists 3 primary outcomes in all. 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 10 Jan 2024.