Intracranial AneurysmSCATNCT03269942
Study of Complex Intracranial Aneurysm Treatment
A study testing Endovascular Flow-Diversion and Cerebral Revascularization in people with Intracranial Aneurysm, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Endovascular Flow-Diversion and Cerebral Revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 14 Mar 2015to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk Research Institution of Circulation Pathology
Novosibirsk, 630055
About this study
Official title: 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.
Read the 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
- Conditions
- Intracranial Aneurysm
- Being tested
- Endovascular Flow-Diversion, Cerebral Revascularization
- Keywords
- Intracranial Aneurysm, Flow Diverter, Cerebral Revascularization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Flow-DiversionProcedure or surgery
Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
Cerebral RevascularizationProcedure or surgery
Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Flow-Diversion | Active comparator | Implantation of flow-diversion device Receives: Procedure: Endovascular Flow-Diversion |
| Cerebral Revascularization | Active comparator | Cerebral revascularization procedure with trapping of aneurysm Receives: Procedure: Cerebral Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS
Change from baseline modified Rankin Scale
Measured: 6, 12 months after procedure
Secondary outcomes (2)
Complete aneurysm occlusion
Measured as: complete occlusion or residual aneurysm (included neck remnant)
Measured: 6, 12 months after procedure
Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Measured: 6, 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start14 Mar 2015
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269942
- Sponsor's protocol ID
- SCAT
- Acronym
- SCAT
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation
- ClinicalTrials.gov ID
- NCT03269942
- Acronym / sponsor ID
- SCAT / SCAT
- Conditions
- Intracranial Aneurysm
- Keywords
- Intracranial Aneurysm, Flow Diverter, Cerebral Revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 14 Mar 2015 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Flow-Diversion | Active comparator | Procedure: Endovascular Flow-DiversionImplantation of flow-diversion device |
| Cerebral Revascularization | Active comparator | Procedure: Cerebral RevascularizationCerebral revascularization procedure with trapping of aneurysm |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Flow-DiversionImplantation of flow-diverter in treatment of complex aneurysms of anterior circulation. | Procedure or surgery | Endovascular Flow-Diversion |
| Cerebral RevascularizationCerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation. | Procedure or surgery | Cerebral Revascularization |
Primary outcome
mRS
Time frame: 6, 12 months after procedure
Change from baseline modified Rankin Scale
2 secondary outcomes
Complete aneurysm occlusion
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Flow-Diversion and Cerebral Revascularization in people with Intracranial Aneurysm, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS (time frame: 6, 12 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.