Abdominal Aortic AneurysmNCT04409717
Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks
An observational study of Abdominal Aortic Aneurysm, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Type II endoleak treatment
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 26 May 2020
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated for type II endoleaks by endovascular therapy between the 01 January 2008 and the 31 December 2018
Who may be able to join
- All patients treated for type II endoleaks by endovascular therapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Type II endoleak treatment
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type II endoleak treatmentProcedure or surgery
Type II endoleak endovascular treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for type II endoleaks | Patients treated for type II endoleaks between the 01 January 2008 and the 31 March 2018 in the Cardiovascular and Thoracic Surgery Unit of Dijon Burgundy University Hospital Receives: Procedure: Type II endoleak treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of type II endoleaks treated with endovascular intervention
Measured: 12 years
Secondary outcomes (1)
Type of type II endoleaks treatment
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jan 2020
- Primary completion26 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric STEINMETZ, Centre Hospitalier Universitaire Dijon
- Investigators
- Eric STEINMETZ, MD, Principal investigator, Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409717
- Sponsor's protocol ID
- CCVT - type 2 endoleaks
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks
- ClinicalTrials.gov ID
- NCT04409717
- Acronym / sponsor ID
- CCVT - type 2 endoleaks
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 1 Jun 2020 (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.
Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for type II endoleaks | – | Procedure: Type II endoleak treatmentPatients treated for type II endoleaks between the 01 January 2008 and the 31 March 2018 in the Cardiovascular and Thoracic Surgery Unit of Dijon Burgundy University Hospital |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated for type II endoleaks by endovascular therapy between the 01 January 2008 and the 31 December 2018
Key inclusion criteria (1 listed)
- All patients treated for type II endoleaks by endovascular therapy
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 |
|---|---|---|
| Type II endoleak treatmentType II endoleak endovascular treatment | Procedure or surgery | Patients treated for type II endoleaks |
Primary outcome
Recurrence rate of type II endoleaks treated with endovascular intervention
Time frame: 12 years
1 secondary outcome
Type of type II endoleaks treatment
Time frame: 12 years
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 1 Jun 2020.
- Individual participant dataSharing planned: No. All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.
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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.
Eric STEINMETZ, MD principal investigator
Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Centre Hospitalier Universitaire Dijon at 1 site 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Recurrence rate of type II endoleaks treated with endovascular intervention (time frame: 12 years). 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 1 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.