Intracranial Aneurysm
Conditions
Keywords
Intracranial Aneurysm, Flow Diverter, Cerebral Revascularization
Brief summary
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
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
Interventions
PROCEDUREEndovascular Flow-Diversion
Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
PROCEDURECerebral Revascularization
Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mRS | 6, 12 months after procedure | Change from baseline modified Rankin Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete aneurysm occlusion | 6, 12 months after procedure | Measured as: complete occlusion or residual aneurysm (included neck remnant) |
| Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm | 6, 12 months after procedure | — |
Countries
Russia
Outcome results
None listed