Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial

NCT04548856 | Unknown

• 1 other identifier: MONICA - Trial
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ruptured Cerebral Aneurysm; Unruptured Cerebral Aneurysm

Keywords

Cerebral Aneurysm; Subarachnoid hemorrhage; Endovascular; Clipping; Embolization; Coiling

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale (mRS)

  Assessment of the clinical condition of patients will be carried out according to the modified Rankin scale (mRS). Primary Outcome Measure is modified Rankin Scale \< or = to 2. mRS will be studied before surgery, after surgery, 6 and 12 months after discharge. Also the dynamics of changes in mRS compared with the baseline values will be analyzed. The null hypothesis is that no difference in outcome will be detected between the endovascular and surgical treatment arms. A statistically significant difference will then be considered evidence in favor of the alternative hypothesis, that one treatment is superior to the other.

  6 and 12 months after discharge

Secondary Outcomes (6)

• Death

  12 months

• Grading the occlusion of treated cerebral aneurysms

  12 months

• Aneurysm recanalization

  12 months

• Reoperations

  12 months

• Periprocedural complications

  12 months

Study Arms (4)

IA-Microsurgical clipping group (ruptured aneurysms)

OTHER

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

Procedure: Microsurgical clipping

IB-Microsurgical clipping group (unruptured aneurysms)

OTHER

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

Procedure: Microsurgical clipping

IIA-Endovascular embolization group (ruptured aneurysms)

OTHER

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

Procedure: Endovascular embolization

IIB-Endovascular embolization group (unruptured aneurysms)

OTHER

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

Procedure: Endovascular embolization

Interventions

Microsurgical clipping PROCEDURE

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

IA-Microsurgical clipping group (ruptured aneurysms); IB-Microsurgical clipping group (unruptured aneurysms)

Endovascular embolization 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.

IIA-Endovascular embolization group (ruptured aneurysms); IIB-Endovascular embolization group (unruptured aneurysms)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moscow Regional Research and Clinical Institute (MONIKI): lead

MeSH Terms

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Boris B Gegenava, Ph.D.

CONTACT

+79258383869; gegenava_boris@dr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endovascolar surgery Chief

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: September 14, 2020
• Primary Completion: September 14, 2023
• Study Completion: May 20, 2025
• Last Updated: September 16, 2020

Record last verified: 2020-09