An interventional study of Microsurgical clipping and Endovascular embolization in Ruptured Cerebral Aneurysm and Unruptured Cerebral Aneurysm, sponsored by Moscow Regional Research and Clinical Institute (MONIKI). Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Moscow Regional Research and Clinical Institute (MONIKI) · Not applicable, Interventional, and Treatment
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.
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 4 is below the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Moscow Regional Research and Clinical Institute (MONIKI) is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm
Procedure: Microsurgical clipping
This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm
Procedure: Microsurgical clipping
This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm
Procedure: Endovascular embolization
This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm
Procedure: Endovascular embolization
Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.
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.
Time frame: 6 and 12 months after discharge
Death
Death associated with an underlying disease or its complication, or complication after surgery
Time frame: 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
Time frame: 12 months
Aneurysm recanalization
Recanalization of the aneurysm after surgery will be assessed by cerebral angiography after 12 months
Time frame: 12 months
Reoperations
Additional operations on the target aneurysm after the initial intervention
Time frame: 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.
Time frame: 12 months
Stroke
Ischemic or hemorrhagic stroke in the target artery
Time frame: 12 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Moscow Regional Research and Clinical Institute (MONIKI)