NCT03269942

Study of Complex Intracranial Aneurysm Treatment

Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Endovascular Flow-Diversion	Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
PROCEDURE	Cerebral Revascularization	Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.

Timeline

• Start date: 2015-03-14
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2017-09-01
• Last updated: 2017-09-01

Locations

1 site across 1 country: Russia