- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548856
Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial (MONICA)
September 8, 2020 updated by: Boris Gegenava, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Boris B Gegenava, Ph.D.
- Phone Number: +79258383869
- Email: gegenava_boris@dr.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: IA-Microsurgical clipping group (ruptured aneurysms)
This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm
|
Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
|
Other: IB-Microsurgical clipping group (unruptured aneurysms)
This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm
|
Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
|
Other: IIA-Endovascular embolization group (ruptured aneurysms)
This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm
|
Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment.
Endovascular treatment will include all modern accepted surgical techniques.
|
Other: IIB-Endovascular embolization group (unruptured aneurysms)
This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm
|
Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment.
Endovascular treatment will include all modern accepted surgical techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 and 12 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 12 months
|
Death associated with an underlying disease or its complication, or complication after surgery
|
12 months
|
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
|
12 months
|
Aneurysm recanalization
Time Frame: 12 months
|
Recanalization of the aneurysm after surgery will be assessed by cerebral angiography after 12 months
|
12 months
|
Reoperations
Time Frame: 12 months
|
Additional operations on the target aneurysm after the initial intervention
|
12 months
|
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.
|
12 months
|
Stroke
Time Frame: 12 months
|
Ischemic or hemorrhagic stroke in the target artery
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 14, 2020
Primary Completion (Anticipated)
September 14, 2023
Study Completion (Anticipated)
May 20, 2025
Study Registration Dates
First Submitted
September 8, 2020
First Submitted That Met QC Criteria
September 8, 2020
First Posted (Actual)
September 16, 2020
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 8, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MONICA - Trial
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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