Study of Complex Intracranial Aneurysm Treatment

NCT ID: NCT03269942

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-14

Study Completion Date

2018-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endovascular Flow-Diversion

Implantation of flow-diversion device

Group Type ACTIVE_COMPARATOR

Endovascular Flow-Diversion

Intervention Type PROCEDURE

Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.

Cerebral Revascularization

Cerebral revascularization procedure with trapping of aneurysm

Group Type ACTIVE_COMPARATOR

Cerebral Revascularization

Intervention Type PROCEDURE

Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endovascular Flow-Diversion

Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.

Intervention Type PROCEDURE

Cerebral Revascularization

Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novosibirsk Research Institution of Circulation Pathology

Novosibirsk, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCAT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.