Ruptured Cerebral AneurysmMONICANCT04548856
Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial
A study testing Microsurgical clipping and Endovascular embolization in people with Ruptured Cerebral Aneurysm and Unruptured Cerebral Aneurysm, run by Moscow Regional Research and Clinical Institute (MONIKI).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ruptured Cerebral Aneurysm, Unruptured Cerebral Aneurysm
- What is being tested?
- Microsurgical clipping and Endovascular embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2020to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Microsurgical clipping, Endovascular embolization
- Keywords
- Cerebral Aneurysm, Subarachnoid hemorrhage, Endovascular, Clipping, Embolization, Coiling
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical clippingProcedure or surgery
Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
Endovascular embolizationProcedure or surgery
Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.
| Study group | Role | What they receive |
|---|---|---|
| IA-Microsurgical clipping group (ruptured aneurysms) | Other | This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm Receives: Procedure: Microsurgical clipping |
| IB-Microsurgical clipping group (unruptured aneurysms) | Other | This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm Receives: Procedure: Microsurgical clipping |
| IIA-Endovascular embolization group (ruptured aneurysms) | Other | This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm Receives: Procedure: Endovascular embolization |
| IIB-Endovascular embolization group (unruptured aneurysms) | Other | This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm Receives: Procedure: Endovascular embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 and 12 months after discharge
Secondary outcomes (6)
Death
Death associated with an underlying disease or its complication, or complication after surgery
Measured: 12 months
Grading the occlusion of treated cerebral aneurysms
Assessed as total occlusion of the aneurysm or the presence of residual filling of the aneurysm
Measured: 12 months
Aneurysm recanalization
Recanalization of the aneurysm after surgery will be assessed by cerebral angiography after 12 months
Measured: 12 months
Reoperations
Additional operations on the target aneurysm after the initial intervention
Measured: 12 months
Periprocedural complications
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.
Measured: 12 months
Stroke
Ischemic or hemorrhagic stroke in the target artery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start14 Sep 2020 (estimated)
- Primary completion14 Sep 2023 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Boris Gegenava, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548856
- Sponsor's protocol ID
- MONICA - Trial
- Acronym
- MONICA
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04548856
- Acronym / sponsor ID
- MONICA / MONICA - Trial
- Keywords
- Cerebral Aneurysm, Subarachnoid hemorrhage, Endovascular, Clipping, Embolization, Coiling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- 14 Sep 2020 (estimated)
- Primary completion
- 14 Sep 2023 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| IA-Microsurgical clipping group (ruptured aneurysms) | Other | Procedure: Microsurgical clippingThis subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm |
| IB-Microsurgical clipping group (unruptured aneurysms) | Other | Procedure: Microsurgical clippingThis subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm |
| IIA-Endovascular embolization group (ruptured aneurysms) | Other | Procedure: Endovascular embolizationThis subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm |
| IIB-Endovascular embolization group (unruptured aneurysms) | Other | Procedure: Endovascular embolizationThis subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microsurgical clippingSubjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms. | Procedure or surgery | IA-Microsurgical clipping group (ruptured aneurysms), IB-Microsurgical clipping group (unruptured aneurysms) |
| Endovascular embolizationSubjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques. | Procedure or surgery | IIA-Endovascular embolization group (ruptured aneurysms), IIB-Endovascular embolization group (unruptured aneurysms) |
Primary outcome
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 secondary outcomes
Death
Time frame: 12 months
Grading the occlusion of treated cerebral aneurysms
Time frame: 12 months
Aneurysm recanalization
Time frame: 12 months
Reoperations
Time frame: 12 months
Periprocedural complications
Time frame: 12 months
Stroke
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Microsurgical clipping and Endovascular embolization in people with Ruptured Cerebral Aneurysm and Unruptured Cerebral Aneurysm, run by Moscow Regional Research and Clinical Institute (MONIKI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris B Gegenava, Ph.D. (+79258383869, gegenava_boris@dr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) (time frame: 6 and 12 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.