Intracranial AneurysmNCT03957382
Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
An observational study of Intracranial Aneurysm, run by Acandis GmbH at 4 sites in Germany.
Trial summary
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Accero® (heal) Stent
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 4 sitesGermany
- Study dates
- 23 Jul 2019to 1 Mar 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated with Accero® (heal) Stent
Who may be able to join
- Any patient treated with ACCERO® (heal) Stent according to IFU and has signed the informed consent
Who cannot join
- Patient is participating in another clinical trial
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie
Berlin, 12351
Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin
Meppen, 49716
KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie
Recklinghausen, 45657
About this study
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
- Conditions
- Intracranial Aneurysm
- Being tested
- Accero® (heal) Stent
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accero® (heal) StentDevice
The Accero® (heal) Stent will only be used in line with the Instructions For Use (IFU). Patients participating in this PMCF (Post- Market Clinical Follow-up) will not be exposed to any additional risk. There are no additional treatments or investigations other than done in the clinical routine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Raymond Roy Classification
Assessment of Raymond Roy Classification
Measured: 6 months after treatment
Raymond Roy Classification
Assessment of Raymond Roy Classification
Measured: 12 months after treatment
Raymond Roy Classification
Assessment of Raymond Roy Classification
Measured: 24 months after treatment
Raymond Roy Classification
Assessment of Raymond Roy Classification
Measured: 36 months after treatment
Secondary outcomes (4)
modified Rankin Scale (mRS)
Assessment of modified Rankin Scale
Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.
The scale runs from 0-6:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 6 months after treatment
modified Rankin Scale (mRS)
Assessment of modified Rankin Scale
Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.
The scale runs from 0-6:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 12 months after treatment
modified Rankin Scale (mRS)
Assessment of modified Rankin Scale
Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.
The scale runs from 0-6:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 24 months after treatment
modified Rankin Scale (mRS)
Assessment of modified Rankin Scale
Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities.
The scale runs from 0-6:
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 36 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 posted21 May 2019
- Study start23 Jul 2019
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maxim Bester, PD. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957382
- Sponsor's protocol ID
- 1041-1
- Status last verified
- Nov 2025
- First submitted
- 16 May 2019
- Last updated
- 21 Nov 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
- ClinicalTrials.gov ID
- NCT03957382
- Acronym / sponsor ID
- 1041-1
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 21 May 2019 (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.
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated with Accero® (heal) Stent
Key inclusion criteria (1 listed)
- Any patient treated with ACCERO® (heal) Stent according to IFU and has signed the informed consent
Key exclusion criteria (1 listed)
- Patient is participating in another clinical trial
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 |
|---|---|---|
| Accero® (heal) StentThe Accero® (heal) Stent will only be used in line with the Instructions For Use (IFU). Patients participating in this PMCF (Post- Market Clinical Follow-up) will not be exposed to any additional risk. There are no additional treatments or investigations other than done in the clinical routine. | Device | – |
Primary outcome
Raymond Roy Classification
Time frame: 6 months after treatment
Assessment of Raymond Roy Classification
Raymond Roy Classification
Time frame: 12 months after treatment
Assessment of Raymond Roy Classification
Raymond Roy Classification
Time frame: 24 months after treatment
Assessment of Raymond Roy Classification
Raymond Roy Classification
Time frame: 36 months after treatment
Assessment of Raymond Roy Classification
4 secondary outcomes
modified Rankin Scale (mRS)
Time frame: 6 months after treatment
modified Rankin Scale (mRS)
Time frame: 12 months after treatment
modified Rankin Scale (mRS)
Time frame: 24 months after treatment
modified Rankin Scale (mRS)
Time frame: 36 months after treatment
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 21 Nov 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. This study is not recruiting at the moment.
Maxim Bester, PD. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Acandis GmbH at 4 sites in Germany.
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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
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?
Raymond Roy Classification (time frame: 6 months after treatment). The study lists 4 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 21 Nov 2025.