An interventional study of Clinical and imaging surveillance and Endovascular or neurosurgical aneurysm treatment in Unruptured Intracranial Aneurysm and Intracranial Aneurysm, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Among 66 studies in Intracranial Aneurysm with a site in France — 20 open to participants now, 27 under way, 1 of them phase 3. Intracranial Aneurysm · France.
Among the 66 studies in Intracranial Aneurysm with a site in France, this one is the 4th largest by planned enrollment of the 23 interventional ones that give a count, is one of 6 that started in 2026, is one of 18 with no phase, reaches primary completion later than 21 of the 26 other live ones, and was the 65th registered.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
Browse Intracranial Aneurysm studies →20 of the 66 studies in Intracranial Aneurysm with a site in France are open now. Recruiting first, the newest first:
Resolve Stroke · Sites in France
Ages 18+
CHU de Reims · Sites in France
Ages 18+
Sim&Cure · Sites in France
Ages 18+
Phenox GmbH · Sites in France, Germany, Italy and 2 more countries
Artiria Medical · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 35 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
66 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 100 across 207 interventional studies indexed under Intracranial Aneurysm.
Median enrollment 171 across the 23 interventional studies, 206 across the 43 observational. Of the 36 that completed or were terminated, 5 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
37 of 66 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 1 study filed under Intracranial Aneurysm — fewer than ten, so there is no comparison to draw.
5 of the studies in Intracranial Aneurysm with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04192955Phase 3University of CalgaryEvaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms | 2027-03 |
| NCT07864389Resolve StrokeMultimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms | 2026-11 |
| NCT06940934Acandis GmbHPost-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE | 2026-12 |
| NCT06972953Artiria MedicalNEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I) | 2026-12 |
| NCT06689410Nantes University HospitalMultimodal Biocollection Linked to the French Register of Intracranial Aneurysms | 2027-03-25 |
Among the 66 studies in Intracranial Aneurysm with a site in France, from their registry updates:
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The goal of this clinical trial is to determine whether a watchful waiting strategy with imaging surveillance is superior to immediate aneurysm treatment in adults with incidentally discovered unruptured intracranial aneurysms (UIAs).
The main questions it aims to answer are:
Researchers will compare two management strategies:
Participants will:
The study includes adults aged 35 years or older with incidentally discovered, non-infectious, intradural saccular UIAs measuring between 2.0 mm and 7.9 mm and no history of subarachnoid hemorrhage. The primary objective is to compare the impact of the two management strategies on neurological dependency during follow-up.
Over the past two decades, the development of non-invasive cerebral vascular imaging and the ageing of the Western population have contributed to the diagnosis of an increasing number of fortuitous unruptured intracranial aneurysms (UIAs), of which approximately 80% measure less than 8 mm in diameter. Neuroradiology and neurosurgery teams have long considered that these UIAs should be treated to protect patients from the risk of subarachnoid haemorrhage (SAH).
The medical community is currently deeply divided regarding the management of these incidentally discovered lesions, with some teams advocating systematic treatment, while others favor radiological surveillance. This divergence reflects a significant degree of uncertainty, thereby justifying the undertaking of a prospective randomized study comparing treatment strategies with surveillance.
The STAF study is designed to evaluate whether a conservative management strategy based on watchful waiting and imaging surveillance is superior to immediate aneurysm treatment with regard to long-term neurological outcomes. The study hypothesis is that patients undergoing immediate aneurysm treatment will experience a higher rate of clinically significant neurological disability than patients managed conservatively. Clinically significant disability is defined as a modified Rankin Scale (mRS) score ≥2 persisting for more than 90 days.
STAF is a prospective, national, multicenter, randomized, open-label, parallel-group trial with adjudication of events ("Prospective Randomized Open-label Blinded Endpoint" PROBE study design). Approximately 7 to 10 neuroradiology and neurosurgery centers across France will participate and recrute in the study.
This study enrolls adult participants with incidentally discovered UIAs. Following incidental aneurysm detection during routine clinical care, patients will be referred to an interventional neuroradiologist or neurosurgeon. During the screening visit, aneurysm characteristics and eligibility criteria will be assessed, and study information will be provided.
Eligible patients will return for an inclusion visit within three months, during which eligibility will be confirmed, written informed consent obtained, and randomization performed. Randomization will be conducted through an Interactive Web Response System (IWRS) using a 1:1 allocation ratio between the two study groups. Randomization will be stratified by participating center, age category (35-55 years versus 56-75 years), and aneurysm size (\<5 mm versus ≥5 mm).
Participants randomized to the intervention strategy will undergo selective aneurysm treatment according to standard clinical practice, including either endovascular or neurosurgical treatment as determined by the treating physicians. Participants randomized to the watchful waiting strategy will receive no initial selective aneurysm treatment.
All participants will be followed according to routine clinical practice, including annual consultation visits and cerebral imaging performed in accordance with current American Heart Association/American Stroke Association recommendations. To ensure regular assessment of functional status from screening to the end-of-study visit, participants will also be contacted annually by a brief telephone follow-up, scheduled approximately 6 months after their previous on-site visit.
All randomized patients will be followed for a minimum of 3,5 years (i.e. 42 months for the last included patients) to a maximum of 6,5 years (i.e. 78 months for the first included patients) with a mean follow-up of 5 years.
Because of the prolonged follow-up period and the possibility of clinical events unrelated to aneurysm disease or treatment, all major study outcomes will be independently adjudicated to determine whether they are related or unrelated to aneurysm progression or treatment.
The primary objective is to compare the effect of immediate aneurysm treatment versus watchful waiting on neurological dependency during follow-up. Secondary objectives include comparison of subarachnoid hemorrhage rates, evaluation of the safety, assessment of treated aneurysm anatomical outcomes through imaging review and economic evaluation of the two management strategies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the watchful waiting strategy will receive no immediate preventive treatment of the unruptured intracranial aneurysm. This strategy consists of initial non-interventional management with standard clinical follow-up and annual brain imaging according to standard care. In the case of patients with multiple aneurysms, all aneurysms will be monitored under the same watchful waiting protocol. Selective treatment is not performed at baseline, but may be considered during follow-up if clinically indicated.
Other: Clinical and imaging surveillance
Participants undergo immediate preventive treatment of the incidentally discovered unruptured intracranial aneurysm using standard endovascular or neurosurgical techniques. Post-procedural follow-up is conducted according to standard care (clinical follow-up and annual brain imaging).
Procedure: Endovascular or neurosurgical aneurysm treatment
Participants undergo active surveillance of incidentally discovered unruptured intracranial aneurysms without initial preventive treatment. Management includes routine neurological follow-up and brain annual imaging according to routine clinical practice. Imaging consists of a 3D Time-of-Flight Magnetic Resonance Imaging (TOF MRI) sequence (or contrast-free CT (Computed-Tomography) and CT angiography of the circle of Willis in case of contraindications, and catheter angiogram with 3D if needed). Treatment will only be considered in the presence of predefined criteria suggestive of increased aneurysm related risk (e.g., aneurysm growth or clinical deterioration).
Participants undergo immediate preventive treatment of the unruptured intracranial aneurysm according to standard clinical practice. Treatment modalities include endovascular procedures (e.g., coiling, stent-assisted coiling, flow diversion) or neurosurgical clipping, as determined by the treating physician. For patients with multiple aneurysms (≤7.9 mm), the operating investigator chooses at least one aneurysm to treat, while the treatment of any additional aneurysms is at the discretion of the team. Subsequent follow-up is performed according to standard clinical care (radiological follow-up at least annually, using the technique deemed most appropriate by the team). In case of recanalization, the choice and technique for additional treatment are left to the discretion of the team.
Occurrence of a clinically significant event
The primary outcome is the occurrence of a clinically significant event during follow-up (minimum duration 3.5 years - maximum 6.5 years, mean duration of 5 years). A clinically significant event is defined as the occurrence of a functional disability with a modified Rankin Scale (mRS) score ≥ 2, persisting for more than 90 days, attributable to the natural history of the aneurysm or to its preventive treatment, as adjudicated by an independent committee.
Time frame: From randomization until the occurrence of a mRS score ≥ 2, assessed up to 90 days after occurence by an independent neurologist, blinded to treatment allocation
Distribution of modified Rankin Scale
During follow-up, the mRS score is systematically collected by the investigator at each scheduled study visit and through telephone follow-up ensuring regular assessment of functional status from screening to the end-of-study visit. In order to ensure an independent evaluation of the primary endpoint, predefined mRS assessments will be performed by an independent neurologist, blinded to treatment allocation, at key time points (inclusion or screening visit, at hospital discharge , at the end of the study, and finally in case of functional deterioration identified by the investigator (mRS ≥ 2). The mRS is a widely used scale to measure the degree of disability or dependence in daily activities in patients with neurological or other causes of disability. There are 6 grades of disability from 0 (minimum value i.e. "the patient has no residual symptoms") to 6 (maximum value i.e. "The patient has expired (during the hospital stay or after discharge from the hospital").
Time frame: Through study completion, an average of 5 years
Occurrence of a transient modified Rankin Scale ≥ 3
Occurrence of a transient modified Rankin Scale (mRS) ≥ 3 (disease or treatment-related as judged by an independent committee) during the follow-up period. The mRS is a widely used scale to measure the degree of disability or dependence in daily activities in patients with neurological or other causes of disability. There are 6 grades of disability from 0 (minimum value i.e. "the patient has no residual symptoms") to 6 (maximum value i.e. "The patient has expired (during the hospital stay or after discharge from the hospital"). Grade 3 is for "The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual."
Time frame: Up to the occurrence of a mRS score ≥ 3, assessed by an investigator
SAH occurrence
The rate of subarachnoid haemorrhage (SAH) is evaluated through cerebral imaging in both arms during follow-up.
Time frame: Through study completion, an average of 5 years
Rupture rate
The rupture rate per aneurysm and per year will be calculated in both groups
Time frame: Through study completion, an average of 5 years
Iatrogenic complications
To measure morbidity/mortality of endovascular treatment,all iatrogenic complications will be reviewed by the endpoint adjudication committee to assure quality control on a case-by-case basis. An iatrogenic complication is a treatment-related adverse event following aneurysm intervention, not related to the aneurysm's natural history. Treatment-related mortality or morbidity is defined as any event following endovascular procedure, open surgery, or due to complication of adjunct treatment to endovascular procedure.
Time frame: Through study completion, an average of 5 years
Rate of Unruptured Intracranial Aneurysms-related (UIA) Adverse Events
The rate of novel UIA-related adverse events in both arms during follow-up.
Time frame: Through study completion, an average of 5 years
Classification of treated aneurysms
Classification of treated aneurysms in each study arm according to the Roy-Raymond scale revised in 2020 at the final imaging assessment (centralized Core Lab reading): complete occlusion, neck remnant, residual aneurysm, or neo-pouch formation.
Time frame: through study completion, an average of 5 years
Economic evaluation (cost-utility analysis)
Evaluation of the incremental cost-utility ratio, estimated as the difference in costs divided by the difference in QALYs (Quality-Adjusted Life Years), calculated as the patient-level utility values derived from the Quality of life (EQ5D5L) (at the inclusion visit, during hospitalization, at 9 months, 18 months, 30 months, and 42 months), multiplied by the time intervals, between the two strategies.
Time frame: From inclusion visit until 42 months visit
Economic evaluation (cost-effectiveness analysis)
Evaluation of the incremental cost-effectiveness ratio, estimated as the difference in costs divided by the difference in the rate of 3,5-year adverse events (composite endpoint of mortality and major events) between the two strategies. The cost-effectiveness outcome is measured using the incremental cost-effectiveness ratio (ICER), defined as the difference in the rate of 3,5-year adverse events (composite endpoint of mortality and major events) between the two strategies. Costs include hospitalization, diagnostic tests, medications, outpatient visits, and other healthcare resource utilization collected prospectively during follow-up.
Time frame: From inclusion visit until 42 months visit
Non-aneurysm-related death
Non-aneurysm-related death during follow-up.
Time frame: Through study completion, an average of 5 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2033, 78 months later.
Of 56 non-industry interventional studies with no phase under Intracranial Aneurysm, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 134. This study's planned 78 months is above that.
Counting every sponsor, half of 104 studies reached it within 39 months; a quarter within 22 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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