The investigator expects that endovascular flow-diversion is superior over revascularization by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.
Novosibirsk Research Institution of Circulation Pathology
Novosibirsk, Russia
mRS
Change from baseline modified Rankin Scale
Time frame: 6, 12 months after procedure
Complete aneurysm occlusion
Measured as: complete occlusion or residual aneurysm (included neck remnant)
Time frame: 6, 12 months after procedure
Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Time frame: 6, 12 months after procedure
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