Study of Complex Intracranial Aneurysm Treatment (SCAT)

August 30, 2017 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

110

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 Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Novosibirsk Research Institution of Circulation Pathology

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

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS
Time Frame: 6, 12 months after procedure
Change from baseline modified Rankin Scale
6, 12 months after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete aneurysm occlusion
Time Frame: 6, 12 months after procedure
Measured as: complete occlusion or residual aneurysm (included neck remnant)
6, 12 months after procedure
Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Time Frame: 6, 12 months after procedure
6, 12 months after procedure

Collaborators and Investigators

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

Sponsor

Meshalkin Research Institute of Pathology of Circulation

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 (Actual)

March 14, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAT

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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