Abdominal Aortic AneurysmCOLONEANCT05072509
Assessment of the Endovascular Aortic Aneurysm Repair's (EVAR) Main Body Lateral Movement Impact on the Rate of Reintervention After AAA's Treatment
An observational study of Abdominal Aortic Aneurysm, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 1 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)
Who may be able to join
- Male or female > 18 years old
- All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)
Who cannot join
- Patient in emergency situation (ruptured abdominal aortic aneurysm)
- Life expectancy supposed to be inferior to 1 year
- Legal incapacity or limited capacity
- Pregnant female
- Patient unlikely to cooperate with the study
- Patient without health insurance
Trial locations and contacts
1 site in 1 country.
France1 site
Vascular Surgery Department
Besançon, 25000
Soumia SEBAIHI, 0381218157 ext. +33, ssebaihi@chu-besancon.fr
Lucie SALOMON DU MONT
About this study
Official title: Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm
The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- aortic, endovascular, aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintervention rate
For the the reintervention rate, all the intervention relative to a failure of the EVAR will be taken in account: as - Endoleak - Thrombosis - Conversion to open surgery - Infection - Secondary rupture
Measured: through study completion, an average of 5 years
Lateral movement of the EVAR
The lateral movement is defined by a movement of more than 5 mm.
Measured: through study completion, an average of 5 years
Secondary outcomes (3)
EVAR's movements: other than lateral.
Other than lateral
Measured: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Moving
EVAR's movement in relation to distal or proximal anchorage zones
Measured: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Compliance
The number of CT scanner compared to the number recommended by the Haute Autorité de Santé (HAS)
Measured: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2025 (estimated)
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 de BesanconThe 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Association Le Don du Souffle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072509
- Sponsor's protocol ID
- 2021-598
- Acronym
- COLONEA
- Status last verified
- Oct 2021
- First submitted
- 16 Aug 2021
- Last updated
- 19 Jan 2022
- 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 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT05072509
- Acronym / sponsor ID
- COLONEA / 2021-598
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- aortic, endovascular, aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Association Le Don du Souffle
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 11 Oct 2021 (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 strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)
Key inclusion criteria (2 listed)
- Male or female > 18 years old
- All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)
Key exclusion criteria (6 listed)
- Patient in emergency situation (ruptured abdominal aortic aneurysm)
- Life expectancy supposed to be inferior to 1 year
- Legal incapacity or limited capacity
- Pregnant female
- Patient unlikely to cooperate with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reintervention rate
Time frame: through study completion, an average of 5 years
For the the reintervention rate, all the intervention relative to a failure of the EVAR will be taken in account: as - Endoleak - Thrombosis - Conversion to open surgery - Infection - Secondary rupture
Lateral movement of the EVAR
Time frame: through study completion, an average of 5 years
The lateral movement is defined by a movement of more than 5 mm.
3 secondary outcomes
EVAR's movements: other than lateral.
Time frame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Moving
Time frame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Compliance
Time frame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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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.
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 de Besancon 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintervention rate (time frame: through study completion, an average of 5 years). The study lists 2 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 19 Jan 2022.