Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial (MONICA)

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: IA-Microsurgical clipping group (ruptured aneurysms)
This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm
Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
Other: IB-Microsurgical clipping group (unruptured aneurysms)
This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm
Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
Other: IIA-Endovascular embolization group (ruptured aneurysms)
This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm
Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.
Other: IIB-Endovascular embolization group (unruptured aneurysms)
This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm
Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 and 12 months after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12 months
Death associated with an underlying disease or its complication, or complication after surgery
12 months
Grading the occlusion of treated cerebral aneurysms
Time Frame: 12 months
Assessed as total occlusion of the aneurysm or the presence of residual filling of the aneurysm
12 months
Aneurysm recanalization
Time Frame: 12 months
Recanalization of the aneurysm after surgery will be assessed by cerebral angiography after 12 months
12 months
Reoperations
Time Frame: 12 months
Additional operations on the target aneurysm after the initial intervention
12 months
Periprocedural complications
Time Frame: 12 months
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.
12 months
Stroke
Time Frame: 12 months
Ischemic or hemorrhagic stroke in the target artery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 14, 2020

Primary Completion (Anticipated)

September 14, 2023

Study Completion (Anticipated)

May 20, 2025

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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