HYdrogel Coil Versus Bare Platinum Coil in Recanalization Imaging Data Study
HYBRID
Efficacy of Hydrogel Coil on Endovascular Treatment for Intracranial Aneurysms; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
2 other identifiers
interventional
431
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedOctober 16, 2019
October 1, 2019
5.8 years
November 29, 2011
October 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recanalization within 1 year after embolization
1 year
Secondary Outcomes (8)
aneurysmal rupture within 1 year after embolization
1 year
any event within 30 days after embolization
30 days
aneurysmal retreatment within 1 year after embolization
1 year
aneurysmal rupture and any death within 1 year after embolization
1 year
any stroke within 1 year after embolization
1 year
- +3 more secondary outcomes
Study Arms (2)
Hydrogel coil group
EXPERIMENTALuse Hydrogel Coil as much as be able to use
Bare platinum coil group
ACTIVE COMPARATORuse only bare platinum coil
Interventions
at least one Hydrogel coil have to use for embolization
only bare platinum coil have to use for embolization
Eligibility Criteria
You may qualify if:
- saccular intracranial aneurysm
- endovascular treatment scheduled within 60days after consent
- years old
- unruptured, chronic SAH or acurte SAH Grade 1-III
- mm in size
- year follow up possibel
- independent (mRS 0-2)
- document consent
You may not qualify if:
- previous endovascular treated
- additional aneurysm scheduled of endovascular treatment
- pregnant
- ineligible for study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan
Kobe City General Hospital
Kobe, Hyōgo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nobuyuki Sakai, MD, DMSc
Kobe City Medical Center General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Neurosurgery
Study Record Dates
First Submitted
November 29, 2011
First Posted
January 25, 2012
Study Start
June 1, 2012
Primary Completion
March 1, 2018
Study Completion
June 1, 2019
Last Updated
October 16, 2019
Record last verified: 2019-10