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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Flow-Diversion | Active Comparator | Implantation of flow-diversion device |
|
| Cerebral Revascularization | Active Comparator | Cerebral revascularization procedure with trapping of aneurysm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Flow-Diversion | Procedure | Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mRS | Change from baseline modified Rankin Scale | 6, 12 months after procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk Research Institution of Circulation Pathology | Novosibirsk | 630055 | Russia |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002548 | Cerebral Revascularization |
| ID | Term |
|---|---|
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Cerebral Revascularization | Procedure | Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation. |
|
| 6, 12 months after procedure |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008866 | Microsurgery |