Study of Complex Intracranial Aneurysm Treatment

Not Applicable

• Conditions: Intracranial Aneurysm
• Interventions: Procedure: Cerebral Revascularization; Procedure: Endovascular Flow-Diversion

• Registration Number: NCT03269942
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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 Timeline

• Study Start: 2015-03-14
• Status Verified: 2017-08
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebral Revascularization	Cerebral Revascularization	Cerebral revascularization procedure with trapping of aneurysm
Endovascular Flow-Diversion	Endovascular Flow-Diversion	Implantation of flow-diversion device

Primary Outcome Measures

Name	Time	Method
mRS	6, 12 months after procedure	Change from baseline modified Rankin Scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novosibirsk Research Institution of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation