Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial

NCT ID: NCT04548856

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2025-05-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IA-Microsurgical clipping group (ruptured aneurysms)

This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm

Group Type: OTHER

Microsurgical clipping

Intervention Type: PROCEDURE

Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.

IB-Microsurgical clipping group (unruptured aneurysms)

This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm

Group Type: OTHER

Microsurgical clipping

Intervention Type: PROCEDURE

Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.

IIA-Endovascular embolization group (ruptured aneurysms)

This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm

Group Type: OTHER

Endovascular embolization

Intervention Type: PROCEDURE

Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.

IIB-Endovascular embolization group (unruptured aneurysms)

This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm

Group Type: OTHER

Endovascular embolization

Intervention Type: PROCEDURE

Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.

Interventions

Microsurgical clipping

Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with ruptured (acute SAH) or unruptured cerebral aneurysm who require surgical treatment (clipping and / or embolization)
• Both male and female
• Age from 18 to 80 years
• Informed consent to participate in the study signed by the patient. If the patient cannot give consent, informed consent is signed by closest relatives or based on the results of a medical concilium
• The patient (legal representative) agrees to a clinical assessment (examination and / or telephone visit) within 6 months and 12 months and to an angiographic control after 12 months
• Patient has not previously been randomized to this or other ongoing study
• Aneurysm has not previously been treated with endovascular embolization or microsurgical clipping

Exclusion Criteria

• The target aneurysm has been treated (embolization or clipping) before
• Severe clinical condition of the patient (Glasgow coma scale <4, unstable hemodynamics)
• Lack of signed informed consent
• Severe medical or surgical comorbidity in which the patient's life expectancy is less than 2 years
• Pregnancy, breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moscow Regional Research and Clinical Institute (MONIKI)

OTHER_GOV

Sponsor Role: lead

Responsible Party

Boris Gegenava

Endovascolar surgery Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Boris B Gegenava, Ph.D.

Role: CONTACT

gegenava_boris@dr.com

+79258383869

Other Identifiers

MONICA - Trial

Identifier Type: -

Identifier Source: org_study_id