Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial
4 participantsStarted 2020-09-14
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
modified Rankin Scale (mRS)
Timeframe: 6 and 12 months after discharge
Trial details
NCT IDNCT04548856
SponsorMoscow Regional Research and Clinical Institute (MONIKI)