Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial — MONICA  

Unruptured Cerebral Aneurysm Clinical Trial

Official title: Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial

Status Not yet recruiting

Clinical Trial Summary

Despite the active development of surgical methods of treatment (endovascular embolization and microsurgical clipping) of cerebral aneurysms, determining the indications and method of surgical treatment of cerebral aneurysms still causes debate in many cases. To a greater extent, this concerns the treatment of unruptured aneurysms. While there are a number of randomized trials of surgical treatment of ruptured cerebral aneurysms, there is currently no published randomized trial comparing surgical clipping and endovascular embolization of unruptured aneurysms. The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular embolization of cerebral aneurysms (both ruptured and unruptured) in a prospective, randomized fashion.

Clinical Trial Description

The study is planned to include 200 patients. Before randomization, patients will be stratified according to the presence or absence of aneurysm rupture in the acute period. The stratified patients will be randomized into two groups (100 to the microsurgical clipping group and 100 to the endovascular embolization group). Each group will be divided into 2 subgroups of 50 people each: the first subgroup includes patients in the acute period of aneurysm rupture, the second subgroup includes patients with unruptured aneurysms. Patients will be followed postoperatively, outcome endpoints will be assessed at discharge, 6 and 12 months. At discharge and after 6 and 12 months, patients will be assessed clinically using a modified Rankin scale (mRS). Cerebral angiography will be performed intraoperatively (endovascular group), after surgery (microsurgical group) and 12 months after discharge (both groups). Thus, the outcome of surgical treatment, including periprocedural complications and mortality, will be assessed both clinically and angiographically. ;

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Ruptured Cerebral Aneurysm
• Unruptured Cerebral Aneurysm

• NCT number: NCT04548856
• Study type: Interventional
• Source: Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
• Contact: Boris B Gegenava, Ph.D.
• Phone: +79258383869
• Email: gegenava_boris@dr.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 14, 2020
• Completion date: May 20, 2025