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 range18 Years – 80 Years
SexALL
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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
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)