Surveillance Versus Treatment of Unruptured Intracranial Aneurysms of Fortuitous Discovery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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:
* Does watchful waiting reduce the risk of clinically significant neurological disability compared with immediate treatment? * How do the two strategies compare in terms of aneurysm rupture, treatment-related complications, quality of life, anatomical outcomes, and healthcare costs?
Researchers will compare two management strategies:
* Immediate selective treatment of the aneurysm (endovascular or neurosurgical treatment according to standard practice). * Watchful waiting with regular clinical and imaging follow-up and no initial aneurysm treatment.
Participants will:
* Be randomly assigned to either immediate treatment or watchful waiting. * Undergo routine clinical assessments and annual brain imaging for at least 42 months. * Complete quality-of-life questionnaires (EQ-5D-5L) at baseline and annually during follow-up. * Participate in annual telephone follow-up assessments, including evaluation of functional outcome using the modified Rankin Scale (mRS). * Undergo a blood or urine pregnancy test at enrollment if they are women of childbearing potential.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
UIA (Unruptured Intracranial Aneurysms) located in an intradural position, with confirmed presence on CT (Computed Tomography) angiography or conventional cerebral angiography.
Largest diameter between 2 mm and 7.9 mm inclusive in height or width (excluding oblique measurements).
Patients with one or more UIAs, provided that at least one aneurysm (index aneurysm) fulfills all inclusion criteria and is selected for study evaluation.
Patients aged ≥ 35 years to 75 years.
Disqualifiers
Aneurysms deemed inoperable by endovascular or surgical techniques, and patients with absolute contraindications to anaesthesia.
Patients with a disease reducing life expectancy to less than 3 years.
Patients with a mRS score of ≥2.
Patients with a history of prior treatment for a cerebral aneurysm (ruptured or unruptured).
Trial design
Design model
Parallel
Treatments tested in this trial
Clinical and imaging surveillance
Other interventionParticipants 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).
Endovascular or neurosurgical aneurysm treatment
Procedure/SurgeryParticipants 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Watchful waiting strategyExperimental treatment 1 intervention
Group B: Intervention strategyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 allocationSecondary outcomes
1
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 years2
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 investigator3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: