Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will collect data about the routine practice in one center of using the WEB in ruptured and unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by assessing the anatomic outcome during follow-up.
Study Type
OBSERVATIONAL
Enrollment
1
The WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/iridium radiopaque markers.
University Hospital Ghent
Ghent, Belgium
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
WEB Occlusion Scale: WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling
Time frame: at 6 months follow-up
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
WEB Occlusion Scale: WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling
Time frame: at 24 months follow-up
Determination of procedural complications (Adverse events) during the operation
Procedural complications: aneurysm rupture, dissection, thromboembolic events (symptomatic and non-symptomatic), device protrusion through the neck of the aneurysm inside the parent artery, detachment problem, device stuck in microcatheter, bleeding.
Time frame: During index-procedure
Recording the use of additional devices during treatment to occlude the aneurysm
Possible additional devices are stent, coils, flow diverter
Time frame: During index-procedure
Determination of the occurrence of post-procedural symptomatic thromboembolic events
Time frame: up to 24 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: at 6 to 8 weeks follow-up
Determination of the technical success of the device defined as device deployment in the target aneurysm as intended by the investigator with complete apposition against the aneurysm wall.
Time frame: During index-procedure
Determination of 30 day mortality
Time frame: up to 30 days
Determination of overall mortality
Time frame: up to 24 months
Recording of intracranial haemorrhage during follow-up
Time frame: up to 24 months
Need for repeat treatment during follow-up
Time frame: up to 24 months
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: at 6 months follow-up
Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)
0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: at 24 months follow-up
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