Unruptured Intracranial AneurysmsACETNCT02862756
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms
A study testing diffusion-weighted MRI and clinical examination in people with Unruptured Intracranial Aneurysms, run by CHU de Reims at 1 site in France.
Trial summary
Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Intracranial Aneurysms
- What is being tested?
- diffusion-weighted MRI and clinical examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2016to 9 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- patient having a programmed endovascular treatment for unruptured intracranial aneurysm
- patient older than 18 years
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
Who cannot join
- patients with contraindications for MRI
- patients whose clinical condition does not allow sufficient cooperation to the realization of MRI
- patients with arteriovenous malformation intracranial
Trial locations and contacts
1 site in 1 country.
About this study
Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.
Read the detailed description
In this multicenter, prospective study, patients with treatment of unruptured intracranial aneurysms will be recruited. The thromboembolic complications will be research using diffusion-weighted MRI.
- Conditions
- Unruptured Intracranial Aneurysms
- Being tested
- diffusion-weighted MRI and clinical examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion-weighted MRI and clinical examinationOther
| Study group | Role | What they receive |
|---|---|---|
| patient with endovascular treatment | Experimental | Not described Receives: Other: diffusion-weighted MRI and clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic complication
Thromboembolic complication diagnosed using diffusion-weighted MRI
Measured: 72 hours after endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start14 Nov 2016
- Primary completion12 Mar 2020
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862756
- Sponsor's protocol ID
- PR16021*
- Acronym
- ACET
- Status last verified
- Mar 2021
- First submitted
- 8 Aug 2016
- Last updated
- 13 May 2021
- Results posted
- No
Publications
Pierot L, Rouchaud A, Chabert E, Desal H, Ricolfi F, Barbe C, Soize S, Zerroug A, Eugene F, Clarencon F, Ferre JC. Endovascular treatment of unruptured intracranial aneurysms: Rate of thromboembolic events depicted by diffusion-weighted imaging in relation to different techniques. J Neurointerv Surg. 2025 Aug 13;17(9):949-955. doi: 10.1136/jnis-2024-022051.
PubMed 39095086
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT02862756
- Acronym / sponsor ID
- ACET / PR16021*
- Conditions
- Unruptured Intracranial Aneurysms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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 of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.
Detailed description
In this multicenter, prospective study, patients with treatment of unruptured intracranial aneurysms will be recruited. The thromboembolic complications will be research using diffusion-weighted MRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with endovascular treatment | Experimental | Other: diffusion-weighted MRI and clinical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient having a programmed endovascular treatment for unruptured intracranial aneurysm
- patient older than 18 years
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
Key exclusion criteria (3 listed)
- patients with contraindications for MRI
- patients whose clinical condition does not allow sufficient cooperation to the realization of MRI
- patients with arteriovenous malformation intracranial
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 |
|---|---|---|
| diffusion-weighted MRI and clinical examination | Other | patient with endovascular treatment |
Primary outcome
Thromboembolic complication
Time frame: 72 hours after endovascular treatment
Thromboembolic complication diagnosed using diffusion-weighted MRI
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 13 May 2021.
- Derived from this study: PubMed 39095086Pierot L, Rouchaud A, Chabert E, Desal H, Ricolfi F, Barbe C, Soize S, Zerroug A, Eugene F, Clarencon F, Ferre JC. Endovascular treatment of unruptured intracranial aneurysms: Rate of thromboembolic events depicted by diffusion-weighted imaging in relation to different techniques. J Neurointerv Surg. 2025 Aug 13;17(9):949-955. doi: 10.1136/jnis-2024-022051.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted MRI and clinical examination in people with Unruptured Intracranial Aneurysms, run by CHU de Reims 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 4 inclusion and 3 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 13 May 2021. 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?
Thromboembolic complication (time frame: 72 hours after endovascular treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862756, which also lists 1 linked publication.
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 13 May 2021.