Aortic DiseasesLEAKDYNNCT06318780
Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis
A study testing three-phase CT angiography and CEUS ultrasound in people with Aortic Diseases, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases
- What is being tested?
- three-phase CT angiography and CEUS ultrasound
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2024to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients 18 years of age and older,
- Patients who have received EVAR ,
- Detection of endoleak and/or with an aneurysmal sac enlargement greater than or equal to 5 mm over 6 months.
Who cannot join
- Minor patients,
- absence of endoleak and growth of the aneurysmal sac (greater than or equal to 5 mm over 6 months),
- patient under guardianship, curators, safeguard of justice,
- patient deprived of liberty,
- pregnant woman
- Patient who does not benefit from a social security scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gabriel IFERGAN, Dr contact
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Thierry REIX, PhD, +33322455929, reix.thierry@chu-amiens.fr
About this study
Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks.
- Conditions
- Aortic Diseases
- Being tested
- three-phase CT angiography, CEUS ultrasound
- Keywords
- EVAR, d-CTA, CEUS
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three-phase CT angiographyOther
three-phase CT angiography
CEUS ultrasoundOther
CEUS ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoleak classification using the CT angiography
Endoleak classification using the CT angiography
Measured: 5 years
Variation of Endoleak classification between CEUS ultrasound and the CT angiography
Variation of Endoleak classification between CEUS ultrasound and the CT angiography
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start28 Feb 2024
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318780
- Sponsor's protocol ID
- PI2023_843_0171
- Acronym
- LEAKDYN
- Status last verified
- May 2025
- First submitted
- 12 Mar 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis
- ClinicalTrials.gov ID
- NCT06318780
- Acronym / sponsor ID
- LEAKDYN / PI2023_843_0171
- Conditions
- Aortic Diseases
- Keywords
- EVAR, d-CTA, CEUS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 19 Mar 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.
Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age and older,
- Patients who have received EVAR ,
- Detection of endoleak and/or with an aneurysmal sac enlargement greater than or equal to 5 mm over 6 months.
Key exclusion criteria (6 listed)
- Minor patients,
- absence of endoleak and growth of the aneurysmal sac (greater than or equal to 5 mm over 6 months),
- patient under guardianship, curators, safeguard of justice,
- patient deprived of liberty,
- pregnant woman
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 |
|---|---|---|
| three-phase CT angiographythree-phase CT angiography | Other | – |
| CEUS ultrasoundCEUS ultrasound | Other | – |
Primary outcome
Endoleak classification using the CT angiography
Time frame: 5 years
Endoleak classification using the CT angiography
Variation of Endoleak classification between CEUS ultrasound and the CT angiography
Time frame: 5 years
Variation of Endoleak classification between CEUS ultrasound and the CT angiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Gabriel IFERGAN, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing three-phase CT angiography and CEUS ultrasound in people with Aortic Diseases, run by Centre Hospitalier Universitaire, Amiens 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 3 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry REIX, Pr (03.22.08.72.65, reix.thierry@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoleak classification using the CT angiography (time frame: 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 25 May 2025.