Stent EmbolisationNCT01702584
Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms
An observational study of Stent Embolisation, run by Kobe City General Hospital at 1 site in Japan.
Trial summary
Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stent Embolisation
- What is being tested?
- stent assisted embolization
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2012to Mar 2021
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stent assisted embolization of intracranial aneurysm
Who may be able to join
- stent assisted embolization of intracranial aneurysm
- 20 or more year old
Who cannot join
- not determined
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Nobuyuki Sakai, MD, DMSc, 81783024321 ext. 080, n.sakai@siren.ocn.ne.jp
About this study
Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.
Read the detailed description
To evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event (death, stroke, hemorrhagic event) prospectively.
- Conditions
- Stent Embolisation
- Being tested
- stent assisted embolization
- Keywords
- stent, intracranial aneurysm, embolization, adverse event
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stent assisted embolizationProcedure or surgery
Also called Enterprise VRD
stent assisted embolization and anti-thrombotic management
| Study group | Role | What they receive |
|---|---|---|
| stent assisted embolization | stent assisted embolization of intracranial aneurysm Receives: Procedure: stent assisted embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
any death, stroke and major hemorrhagic event
any death, stroke and major hemorrhagic event within 2 years after treatment
Measured: 2 years after treatment
Secondary outcomes (1)
any adverse event
- death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment
- any change of anti-thrombotic therapy within 2years after treatment
- recanalization or re-treatment within 2years after treatment
- stent stenosis or occlusion within 2years after treatment
- any adverse event within 2years after treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2018
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stent EmbolisationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe City General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuyuki Sakai, Kobe City General Hospital
- Investigators
- Nobuyuki Sakai, MD, DMSc, Principal investigator, Kobe City Medical Center General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702584
- Sponsor's protocol ID
- TRIBRAIN1204
- Other IDs
- UMIN000010405
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2012
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms
- ClinicalTrials.gov ID
- NCT01702584
- Acronym / sponsor ID
- TRIBRAIN1204
- Conditions
- Stent Embolisation
- Keywords
- stent, intracranial aneurysm, embolization, adverse event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kobe City General HospitalUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 8 Oct 2012 (estimated)
- 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.
Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.
Detailed description
To evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event (death, stroke, hemorrhagic event) prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stent assisted embolization | – | Procedure: stent assisted embolizationstent assisted embolization of intracranial aneurysm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stent assisted embolization of intracranial aneurysm
Key inclusion criteria (2 listed)
- stent assisted embolization of intracranial aneurysm
- 20 or more year old
Key exclusion criteria (1 listed)
- not determined
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 |
|---|---|---|
| stent assisted embolizationAlso: Enterprise VRDstent assisted embolization and anti-thrombotic management | Procedure or surgery | stent assisted embolization |
Primary outcome
any death, stroke and major hemorrhagic event
Time frame: 2 years after treatment
any death, stroke and major hemorrhagic event within 2 years after treatment
1 secondary outcome
any adverse event
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
Nobuyuki Sakai, MD, DMSc principal investigator
Kobe City Medical Center General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stent Embolisation, run by Kobe City General Hospital at 1 site in Japan.
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 2 inclusion and 1 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 9 Sep 2020. 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 Japan. 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?
Contact Nobuyuki Sakai, MD, DMSc (81783024321 ext. 080, n.sakai@siren.ocn.ne.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
any death, stroke and major hemorrhagic event (time frame: 2 years after treatment). 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 9 Sep 2020.