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Study of Complex Intracranial Aneurysm Treatment (SCAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03269942
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Procedure: Endovascular Flow-Diversion Procedure: Cerebral Revascularization Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation
Actual Study Start Date : March 14, 2015
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Endovascular Flow-Diversion
Implantation of flow-diversion device
Procedure: Endovascular Flow-Diversion
Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.

Active Comparator: Cerebral Revascularization
Cerebral revascularization procedure with trapping of aneurysm
Procedure: Cerebral Revascularization
Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.




Primary Outcome Measures :
  1. mRS [ Time Frame: 6, 12 months after procedure ]
    Change from baseline modified Rankin Scale


Secondary Outcome Measures :
  1. Complete aneurysm occlusion [ Time Frame: 6, 12 months after procedure ]
    Measured as: complete occlusion or residual aneurysm (included neck remnant)

  2. Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm [ Time Frame: 6, 12 months after procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269942


Locations
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Russian Federation
Novosibirsk Research Institution of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03269942     History of Changes
Other Study ID Numbers: SCAT
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Intracranial Aneurysm
Flow Diverter
Cerebral Revascularization

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases