NCT04548856

Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Moscow Regional Research and Clinical Institute (MONIKI) · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ruptured Cerebral Aneurysm
• Unruptured Cerebral Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Microsurgical clipping	Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
PROCEDURE	Endovascular embolization	Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.

Timeline

• Start date: 2020-09-14
• Primary completion: 2023-09-14
• Completion: 2025-05-20
• First posted: 2020-09-16
• Last updated: 2020-09-16