Back to resultsStudy of Complex Intracranial Aneurysm Treatment (SCAT)
Primary Purpose
Intracranial Aneurysm
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Endovascular Flow-Diversion
Cerebral Revascularization
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Intracranial Aneurysm, Flow Diverter, Cerebral Revascularization
Eligibility Criteria
Inclusion Criteria:
- anterior circulation complex intracranial aneurysm
- neck is more than 4 mm wide
- dome/neck ratio of aneurysm equals or less than 2:1
- age less than 75 years
- ability to give informed consent (subject or legally authorized representative)
- aneurysm is suitable for treatment to both procedures
Exclusion Criteria:
- subarachnoid hemorrhage less than 30 days ago
- contraindications to endovascular treatment
- atypical aneurysms (mycotic, flow-related in patients with AVM, traumatic, false)
- informed consent refusal
Sites / Locations
- Novosibirsk Research Institution of Circulation Pathology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Endovascular Flow-Diversion
Cerebral Revascularization
Arm Description
Implantation of flow-diversion device
Cerebral revascularization procedure with trapping of aneurysm
Outcomes
Primary Outcome Measures
mRS
Change from baseline modified Rankin Scale
Secondary Outcome Measures
Complete aneurysm occlusion
Measured as: complete occlusion or residual aneurysm (included neck remnant)
Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Full Information
NCT ID
NCT03269942
First Posted
August 29, 2017
Last Updated
August 30, 2017
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT03269942
Brief Title
Study of Complex Intracranial Aneurysm Treatment
Acronym
SCAT
Official Title
Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2015 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigator expects that endovascular flow-diversion is superior over revascularization by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.
Detailed Description
Open, prospective, controlled randomized superiority trial is conducted. The hypothesis is that endovascular flow-diversion is better than revascularization in treatment of complex intracranial aneurysms by postoperative modified Rankin Scale (mRS). Sample size was measured by Fisher exact test. Depending on a type of the procedure, the patients are divided into two groups: Endovascular Flow Diversion Procedure (include 55 patients) and Revascularization Procedure (include 55 patients). Randomization is performed by random number generation.The study was approved by Institutional Review Board
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Intracranial Aneurysm, Flow Diverter, Cerebral Revascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endovascular Flow-Diversion
Arm Type
Active Comparator
Arm Description
Implantation of flow-diversion device
Arm Title
Cerebral Revascularization
Arm Type
Active Comparator
Arm Description
Cerebral revascularization procedure with trapping of aneurysm
Intervention Type
Procedure
Intervention Name(s)
Endovascular Flow-Diversion
Intervention Description
Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
Intervention Type
Procedure
Intervention Name(s)
Cerebral Revascularization
Intervention Description
Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.
Primary Outcome Measure Information:
Title
mRS
Description
Change from baseline modified Rankin Scale
Time Frame
6, 12 months after procedure
Secondary Outcome Measure Information:
Title
Complete aneurysm occlusion
Description
Measured as: complete occlusion or residual aneurysm (included neck remnant)
Time Frame
6, 12 months after procedure
Title
Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Time Frame
6, 12 months after procedure
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
anterior circulation complex intracranial aneurysm
neck is more than 4 mm wide
dome/neck ratio of aneurysm equals or less than 2:1
age less than 75 years
ability to give informed consent (subject or legally authorized representative)
aneurysm is suitable for treatment to both procedures
Exclusion Criteria:
subarachnoid hemorrhage less than 30 days ago
contraindications to endovascular treatment
atypical aneurysms (mycotic, flow-related in patients with AVM, traumatic, false)
informed consent refusal
Facility Information:
Facility Name
Novosibirsk Research Institution of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Study of Complex Intracranial Aneurysm Treatment
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