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Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial (MONICA)

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ClinicalTrials.gov Identifier: NCT04548856
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Boris Gegenava, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ruptured Cerebral Aneurysm Unruptured Cerebral Aneurysm Procedure: Microsurgical clipping Procedure: Endovascular embolization Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial
Estimated Study Start Date : September 14, 2020
Estimated Primary Completion Date : September 14, 2023
Estimated Study Completion Date : May 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arms and Interventions
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Arm Intervention/treatment
IA-Microsurgical clipping group (ruptured aneurysms)
This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm
 Procedure: Microsurgical clipping
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
 Procedure: Microsurgical clipping
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
 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.
IIB-Endovascular embolization group (unruptured aneurysms)
This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm
 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.


Outcome Measures
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Primary Outcome Measures :
  1. modified Rankin Scale (mRS) [ Time Frame: 6 and 12 months after discharge ]
    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.


Secondary Outcome Measures :
  1. Death [ Time Frame: 12 months ]
    Death associated with an underlying disease or its complication, or complication after surgery

  2. Grading the occlusion of treated cerebral aneurysms [ Time Frame: 12 months ]
    Assessed as total occlusion of the aneurysm or the presence of residual filling of the aneurysm

  3. Aneurysm recanalization [ Time Frame: 12 months ]
    Recanalization of the aneurysm after surgery will be assessed by cerebral angiography after 12 months

  4. Reoperations [ Time Frame: 12 months ]
    Additional operations on the target aneurysm after the initial intervention

  5. Periprocedural complications [ Time Frame: 12 months ]
    Any complications associated with surgical intervention: hematoma in the puncture area, dissection of arteries, postoperative intracranial hematoma, liquorrhea, postoperative meningitis, suppuration of postoperative stitches, neurological complications, etc.

  6. Stroke [ Time Frame: 12 months ]
    Ischemic or hemorrhagic stroke in the target artery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548856


Contacts
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Contact: Boris B Gegenava, Ph.D. +79258383869 gegenava_boris@dr.com

Sponsors and Collaborators
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
More Information
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Responsible Party: Boris Gegenava, Endovascolar surgery Chief, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
ClinicalTrials.gov Identifier: NCT04548856    
Other Study ID Numbers: MONICA - Trial
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boris Gegenava, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy:
Cerebral Aneurysm
Subarachnoid hemorrhage
Endovascular
 Clipping
Embolization
Coiling
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases