Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- mRS
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Endovascular Flow-Diversion
Implantation of flow-diversion device
Intervention: Endovascular Flow-Diversion (Procedure)
Cerebral Revascularization
Cerebral revascularization procedure with trapping of aneurysm
Intervention: Cerebral Revascularization (Procedure)
Outcomes
Primary Outcomes
mRS
Time Frame: 6, 12 months after procedure
Change from baseline modified Rankin Scale
Secondary Outcomes
- Complete aneurysm occlusion(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)