Intracranial AneurysmATLAS-FRNCT04162483
Safety and Performance of the Neuroform Atlas™ Stent System
An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 1 site in France.
Trial summary
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Neuroform Atlas Stent System
- Type of treatment
- Medical device
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2019to 15 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects treated in one of the French Sites participating to the registry and who have been treated with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 01 February 2017 and 01 March 2018.
Who may be able to join
- Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2 018.
- Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Gui de Chauliac
Montpellier, F-34295
Vincent Costalat, v-costalat@chu-montpellier.fr
Marinette Moynier, m-moynier@chu-montpellier.fr
About this study
Official title: Safety and Performance of the Neuroform Atlas™ Stent System in Patients Requiring Stent Assisted Intracranial Aneurysm Treatment in France - A National, Retrospective Multi-center Registry
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.
Read the detailed description
This proposed ATLAS FR study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in France between 01 February 2017 and 01 March 2018.
This will provide a comprehensive data set that is specifically representative of the Atlas stent use in France.
- Conditions
- Intracranial Aneurysm
- Being tested
- Neuroform Atlas Stent System
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroform Atlas Stent SystemDevice
Stenting Assisted coiling procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
permanent morbidity and mortality rate
any major ipsilateral stroke or neurological death
Measured: up to 12-16 months post-procedure
Secondary outcomes (7)
AEs and device malfunctions
All intra-procedural AEs and device malfunctions
Measured: peri-procedure
Efficacy Endpoint with mRS
Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III
Measured: immediately post-procedure and at 12-16 months post procedure
Retreatment
Occurence of re-treatment
Measured: up to 12-16 months
Subarachnoid hemorrhage (SAH)
Occurence of SAH
Measured: Up to 12-16 months
Aneurysm rupture/re-rupture
Occurence of Aneurysm rupture/re-rupture
Measured: Up to 12-16 months
SAEs resulting in neurological death
Rate of SAEs resulting in neurological death
Measured: Up to 12-16 months
device-related SAEs
Occurence of device-related SAEs
Measured: Up to 12-16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start19 Nov 2019
- Primary completion15 May 2021 (estimated)
- Study completion15 Jul 2021 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emmanuel Houdart, MD, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162483
- Sponsor's protocol ID
- T4062
- Acronym
- ATLAS-FR
- Status last verified
- Jun 2020
- First submitted
- 11 Nov 2019
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the Neuroform Atlas™ Stent System in Patients Requiring Stent Assisted Intracranial Aneurysm Treatment in France - A National, Retrospective Multi-center Registry
- ClinicalTrials.gov ID
- NCT04162483
- Acronym / sponsor ID
- ATLAS-FR / T4062
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 14 Nov 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.
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.
Detailed description
This proposed ATLAS FR study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in France between 01 February 2017 and 01 March 2018.
This will provide a comprehensive data set that is specifically representative of the Atlas stent use in France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects treated in one of the French Sites participating to the registry and who have been treated with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 01 February 2017 and 01 March 2018.
Key inclusion criteria (2 listed)
- Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2 018.
- Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Neuroform Atlas Stent SystemStenting Assisted coiling procedure | Device | – |
Primary outcome
permanent morbidity and mortality rate
Time frame: up to 12-16 months post-procedure
any major ipsilateral stroke or neurological death
7 secondary outcomes
AEs and device malfunctions
Time frame: peri-procedure
Efficacy Endpoint with mRS
Time frame: immediately post-procedure and at 12-16 months post procedure
Retreatment
Time frame: up to 12-16 months
Subarachnoid hemorrhage (SAH)
Time frame: Up to 12-16 months
Aneurysm rupture/re-rupture
Time frame: Up to 12-16 months
SAEs resulting in neurological death
Time frame: Up to 12-16 months
device-related SAEs
Time frame: Up to 12-16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Emmanuel Houdart, MD principal investigator
Hopital Lariboisière
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 Aneurysm, run by Stryker Neurovascular 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 0 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 17 Jun 2020. 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?
Contact Caroline Le Page, RN (+33678777761, Caroline.lepage@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
permanent morbidity and mortality rate (time frame: up to 12-16 months post-procedure). 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 17 Jun 2020.