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| Name | Class |
|---|---|
| Archer Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ruptured or unruptured intracranial aneurysms |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB aneurysm embolization system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 6 months |
| 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 | at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during index-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with ruptured or unruptured intracranial aneurysms.
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| Name | Affiliation | Role |
|---|---|---|
| Maurits Voormolen, Prof Dr | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Recording the use of additional devices during treatment. | Possible additional devices are stent, coils, flow diverter | during index-procedure |
| Determination of the occurrence of post-procedural symptomatic thromboembolic events | up to 24 months follow-up |
| Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) | 0 - No symptoms.
| At baseline |
| Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) | 0 - No symptoms.
| at 6 to 8 weeks follow-up |
| Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) | 0 - No symptoms.
| at 6 months follow-up |
| Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS) | 0 - No symptoms.
| at 24 months follow-up |
| Fisher grade (severity of intracranial SAH) for ruptured aneurysms. | Fisher grade: 1 No haemorrhage evident. 2 Subarachnoid haemorrhage less than 1mm thick. 3 Subarachnoid haemorrhage more than 1mm thick. 4 Subarachnoid haemorrhage of any thickness with intraventricular haemorrhage (IVH) or parenchymal extension. | at baseline |
| Determination of technical success of the device | Technical success is defined as device deployment in the target aneurysm as intended by the investigator with adequate occlusion of the aneurysm (WOS A, B or C). | during index-procedure |
| Determination of overall mortality | up to 24 months |
| Recording of intracranial haemorrhage during follow-up | up to 24 months |
| Recording the need for re-intervention during follow-up. | up to 24 months |
| Hunt and Hess scale (severity of clinical effect of SAH) for ruptured aneurysms. | Hunt and Hess scale:
| baseline |