Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial (MONICA)
Ruptured Cerebral Aneurysm, Unruptured Cerebral Aneurysm
About this trial
This is an interventional treatment trial for Ruptured Cerebral Aneurysm focused on measuring Cerebral Aneurysm, Subarachnoid hemorrhage, Endovascular, Clipping, Embolization, Coiling
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
IA-Microsurgical clipping group (ruptured aneurysms)
IB-Microsurgical clipping group (unruptured aneurysms)
IIA-Endovascular embolization group (ruptured aneurysms)
IIB-Endovascular embolization group (unruptured aneurysms)
This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm
This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm
This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm
This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm