Study of Complex Intracranial Aneurysm Treatment
SCAT
Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2015
CompletedFirst Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 1, 2017
August 1, 2017
3.2 years
August 29, 2017
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mRS
Change from baseline modified Rankin Scale
6, 12 months after procedure
Secondary Outcomes (2)
Complete aneurysm occlusion
6, 12 months after procedure
Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
6, 12 months after procedure
Study Arms (2)
Endovascular Flow-Diversion
ACTIVE COMPARATORImplantation of flow-diversion device
Cerebral Revascularization
ACTIVE COMPARATORCerebral revascularization procedure with trapping of aneurysm
Interventions
Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novosibirsk Research Institution of Circulation Pathology
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 1, 2017
Study Start
March 14, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
September 1, 2017
Record last verified: 2017-08