Study of Complex Intracranial Aneurysm Treatment

Study Overview
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Brief Summary
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The investigator expects that endovascular flow-diversion is superior over revascularization by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.

Detailed Description
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Open, prospective, controlled randomized superiority trial is conducted. The hypothesis is that endovascular flow-diversion is better than revascularization in treatment of complex intracranial aneurysms by postoperative modified Rankin Scale (mRS). Sample size was measured by Fisher exact test. Depending on a type of the procedure, the patients are divided into two groups: Endovascular Flow Diversion Procedure (include 55 patients) and Revascularization Procedure (include 55 patients). Randomization is performed by random number generation.The study was approved by Institutional Review Board

Official Title
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Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Procedure: Endovascular Flow-Diversion
* Procedure: Cerebral Revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: anterior circulation complex intracranial aneurysm neck is more than 4 mm wide dome/neck ratio of aneurysm equals or less than 2:1 age less than 75 years ability to give informed consent (subject or legally authorized representative) aneurysm is suitable for treatment to both procedures Exclusion Criteria: subarachnoid hemorrhage less than 30 days ago contraindications to endovascular treatment atypical aneurysms (mycotic, flow-related in patients with AVM, traumatic, false) informed consent refusal

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endovascular Flow-Diversion<br>Implantation of flow-diversion device | Procedure: Endovascular Flow-Diversion<br>* Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.<br>|
| Active Comparator: Cerebral Revascularization<br>Cerebral revascularization procedure with trapping of aneurysm | Procedure: Cerebral Revascularization<br>* Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS | Change from baseline modified Rankin Scale | 6, 12 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete aneurysm occlusion | Measured as: complete occlusion or residual aneurysm (included neck remnant) | 6, 12 months after procedure | 
| Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm |  | 6, 12 months after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flow Diverter, Intracranial Aneurysm, Cerebral Revascularization