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Study of Complex Intracranial Aneurysm Treatment (SCAT)

M

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown

Conditions

Intracranial Aneurysm

Treatments

Procedure: Cerebral Revascularization
Procedure: Endovascular Flow-Diversion

Study type

Interventional

Funder types

NETWORK

Identifiers

Details and patient eligibility

About

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

Full 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

Enrollment

110 patients

Sex

All

Ages

Under 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Endovascular Flow-Diversion
Active Comparator group
Description:
Implantation of flow-diversion device
Treatment:
Procedure: Endovascular Flow-Diversion
Cerebral Revascularization
Active Comparator group
Description:
Cerebral revascularization procedure with trapping of aneurysm
Treatment:
Procedure: Cerebral Revascularization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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