Intracranial AneurysmHYBRIDNCT01516658
HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
A study testing Hydrogel coil and Bare platinum coil in people with Intracranial Aneurysm and Subarachnoid Hemorrhage, run by Kobe City General Hospital at 2 sites in Japan.
Trial summary
HYBRID study is prospective randomized open label controlled multi center trial, to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Intracranial Aneurysm, Subarachnoid Hemorrhage
- What is being tested?
- Hydrogel coil and Bare platinum coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 2 sitesJapan
- Study dates
- Jun 2012to Jun 2019
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- saccular intracranial aneurysm
- endovascular treatment scheduled within 60days after consent
- 20-79 years old
- unruptured, chronic SAH or acurte SAH Grade 1-III
- 7-20mm in size
- 1 year follow up possibel
- independent (mRS 0-2)
- document consent
Who cannot join
- previous endovascular treated
- additional aneurysm scheduled of endovascular treatment
- pregnant
- ineligible for study
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Kobe City General Hospital
Kobe, Hyōgo
Nakamura Memorial Hospital
Sapporo, Hokkaido
About this study
Official title: Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
HYBRID study is prospective randomized open label controlled multi center trial, to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.
Read the detailed description
At least one Hydrocoil have to use in Hydrocoil arm, and only bare platinum coil have to use in Control arm.
Primary endpoint is recanalization within 1 year after embolization, and secondary endpoint are:
- aneurysmal rupture within 1 year after embolization
- any event within 30 days after embolization
- recanalization within 6 months after embolization
- aneurysmal retreatment within 1 year after embolization
- aneurysmal rupture and any death within 1 year after embolization
- any stroke within 1 year after embolization
- any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
- change in aneurysmal occlusion
- any comlicaion within 1 year after embolization
- %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage
- Being tested
- Hydrogel coil, Bare platinum coil
- Keywords
- intracranial aneurysm, endovascular therapy, detachable coil, recanalization
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel coilDevice
Also called Hydrocoil, HydroSoft, HydroFrame
at least one Hydrogel coil have to use for embolization
Bare platinum coilDevice
Also called detachable coil, GDC, Microvention
only bare platinum coil have to use for embolization
| Study group | Role | What they receive |
|---|---|---|
| Hydrogel coil group | Experimental | use Hydrogel Coil as much as be able to use Receives: Device: Hydrogel coil |
| Bare platinum coil group | Active comparator | use only bare platinum coil Receives: Device: Bare platinum coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
recanalization within 1 year after embolization
Measured: 1 year
Secondary outcomes (8)
aneurysmal rupture within 1 year after embolization
Measured: 1 year
any event within 30 days after embolization
Measured: 30 days
aneurysmal retreatment within 1 year after embolization
Measured: 1 year
aneurysmal rupture and any death within 1 year after embolization
Measured: 1 year
any stroke within 1 year after embolization
Measured: 1 year
any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
Measured: 1 year
change in aneurysmal occlusion
Measured: 1 year
any complicaion within 1 year after embolization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2018
- Study completionJun 2019
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
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kobe City General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- 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
- NCT01516658
- Sponsor's protocol ID
- TRIBRAIN1119
- Other IDs
- UMIN000006748
- Acronym
- HYBRID
- Status last verified
- Oct 2019
- First submitted
- 29 Nov 2011
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
- ClinicalTrials.gov ID
- NCT01516658
- Acronym / sponsor ID
- HYBRID / TRIBRAIN1119
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage
- Keywords
- intracranial aneurysm, endovascular therapy, detachable coil, recanalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Kobe City General HospitalUniversity, hospital or other
- Collaborators
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Study start
- Jun 2012 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 25 Jan 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.
HYBRID study is prospective randomized open label controlled multi center trial, to compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.
Detailed description
At least one Hydrocoil have to use in Hydrocoil arm, and only bare platinum coil have to use in Control arm.
Primary endpoint is recanalization within 1 year after embolization, and secondary endpoint are:
- aneurysmal rupture within 1 year after embolization
- any event within 30 days after embolization
- recanalization within 6 months after embolization
- aneurysmal retreatment within 1 year after embolization
- aneurysmal rupture and any death within 1 year after embolization
- any stroke within 1 year after embolization
- any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
- change in aneurysmal occlusion
- any comlicaion within 1 year after embolization
- %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogel coil group | Experimental | Device: Hydrogel coiluse Hydrogel Coil as much as be able to use |
| Bare platinum coil group | Active comparator | Device: Bare platinum coiluse only bare platinum coil |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- saccular intracranial aneurysm
- endovascular treatment scheduled within 60days after consent
- 20-79 years old
- unruptured, chronic SAH or acurte SAH Grade 1-III
- 7-20mm in size
Key exclusion criteria (4 listed)
- previous endovascular treated
- additional aneurysm scheduled of endovascular treatment
- pregnant
- ineligible for study
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 |
|---|---|---|
| Hydrogel coilAlso: Hydrocoil, HydroSoft, HydroFrameat least one Hydrogel coil have to use for embolization | Device | Hydrogel coil group |
| Bare platinum coilAlso: detachable coil, GDC, Microventiononly bare platinum coil have to use for embolization | Device | Bare platinum coil group |
Primary outcome
recanalization within 1 year after embolization
Time frame: 1 year
8 secondary outcomes
aneurysmal rupture within 1 year after embolization
Time frame: 1 year
any event within 30 days after embolization
Time frame: 30 days
aneurysmal retreatment within 1 year after embolization
Time frame: 1 year
aneurysmal rupture and any death within 1 year after embolization
Time frame: 1 year
any stroke within 1 year after embolization
Time frame: 1 year
any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization
Time frame: 1 year
change in aneurysmal occlusion
Time frame: 1 year
any complicaion within 1 year after embolization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogel coil and Bare platinum coil in people with Intracranial Aneurysm and Subarachnoid Hemorrhage, run by Kobe City General Hospital at 2 sites 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 8 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: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
recanalization within 1 year after embolization (time frame: 1 year). 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 16 Oct 2019.