Intracranial AneurysmsANCRAGE PMSNCT06940934
Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
An observational study of Intracranial Aneurysms, run by Acandis GmbH at 1 site in France.
Trial summary
The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to Apr 2027
- Phase
- Observational
- 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
Study population: Each cohort will consist of subjects with an intracranial aneurysm whom the physician wishes to treat with one or more Acandis devices. Each subject will be followed according to the standard of care within the participating sites. All treated (and intended to treat with at least 1 Acandis device inserted) cases will be captured in the ANCRAGE study database, from the date of agreement with French authorities; that means it will be a consecutive prospective enrollment to demonstrate the exhaustivity at the site, even the cases are captured in the database retrospectively. There is a minimum of 50 consecutive cases to be enrolled per device family, from the time the device has been put on the French market and until the needed report to the authorities (for instance the renewal of the device registration/reimbursement).
Who may be able to join
- The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms.
- The subject is 18 years of age or older.
- The subject is willing to comply with scheduled visits and examinations, per institution standard of care.
Who cannot join
- The subject has provided tacit opposition to data collection.
- Any IFU warning will be considered for exclusion in the cohort.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)
Rouen, 76000
Chrysanthi Papagiannaki, Dr., +33 2 32 88 89 90
About this study
Official title: ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.
- Conditions
- Intracranial Aneurysms
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Devices of the DERIVO family | Not described | |
| ACCLINO flex plus Stent | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation, defined as a mRS >/= 3 for the subjects with a baseline mRS between 0 and 2 or mRS increase of 1 point for subjects with a baseline mRS greater than 2.
Measured: 12+/-3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940934
- Sponsor's protocol ID
- ANCRAGE PMS
- Acronym
- ANCRAGE PMS
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 23 Apr 2025
- 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
- ClinicalTrials.gov ID
- NCT06940934
- Acronym / sponsor ID
- ANCRAGE PMS / ANCRAGE PMS
- Conditions
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Apr 2025 (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 aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Devices of the DERIVO family | – | – |
| ACCLINO flex plus Stent | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each cohort will consist of subjects with an intracranial aneurysm whom the physician wishes to treat with one or more Acandis devices. Each subject will be followed according to the standard of care within the participating sites. All treated (and intended to treat with at least 1 Acandis device inserted) cases will be captured in the ANCRAGE study database, from the date of agreement with French authorities; that means it will be a consecutive prospective enrollment to demonstrate the exhaustivity at the site, even the cases are captured in the database retrospectively. There is a minimum of 50 consecutive cases to be enrolled per device family, from the time the device has been put on the French market and until the needed report to the authorities (for instance the renewal of the device registration/reimbursement).
Key inclusion criteria (3 listed)
- The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms.
- The subject is 18 years of age or older.
- The subject is willing to comply with scheduled visits and examinations, per institution standard of care.
Key exclusion criteria (2 listed)
- The subject has provided tacit opposition to data collection.
- Any IFU warning will be considered for exclusion in the cohort.
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
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation
Time frame: 12+/-3 months after treatment
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation, defined as a mRS >/= 3 for the subjects with a baseline mRS between 0 and 2 or mRS increase of 1 point for subjects with a baseline mRS greater than 2.
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 23 Apr 2025.
Related trials for Intracranial Aneurysms
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
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.
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 Intracranial Aneurysms, run by Acandis GmbH 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 2 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 23 Apr 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 Acandis GmbH (+49 7231 980 84 0, clinicalaffairs@acandis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation (time frame: 12+/-3 months after treatment). 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 23 Apr 2025.