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NCT03269942 Clinical Trial

Study of Complex Intracranial Aneurysm Treatment

Intracranial Aneurysm Clinical Trial

— SCAT  

Official title:
Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03269942
Other study ID # SCAT
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 29, 2017
Last updated August 30, 2017
Start date March 14, 2015
Est. completion date June 1, 2018

Study information
Verified date August 2017
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigator expects that endovascular flow-diversion is superior over revascularization by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 110
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endovascular Flow-Diversion
Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
• Cerebral Revascularization
Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.

Locations
Country Name City State
Russian Federation Novosibirsk Research Institution of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary mRS Change from baseline modified Rankin Scale 6, 12 months after procedure
Secondary Complete aneurysm occlusion Measured as: complete occlusion or residual aneurysm (included neck remnant) 6, 12 months after procedure
Secondary Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm 6, 12 months after procedure
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