UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Hydrocoil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, randomized, open-label blind-endpoint trial
Acronym	HYBRID (HYdrocoil versus Bare platinum coil in Recanalization Imaging Data) study
Scientific Title	Efficacy of Hydrocoil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, randomized, open-label blind-endpoint trial
Scientific Title:Acronym	HYBRID (HYdrocoil versus Bare platinum coil in Recanalization Imaging Data) study
Region	Japan

Condition
Condition	Intracranial anerysm
Classification by specialty	Radiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare Hydrocoil and bare platinum coil for recanalization after endovascular treatment of intracranial aneurysms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	recanalization within 1 year after embolization
Key secondary outcomes	1. aneurysmal rupture within 1 year after embolization 2. any event within 30 days after embolization 3. recanalization within 6 months after embolization 4. aneurysmal retreatment within 1 year after embolization 5. aneurysmal rupture and any death within 1 year after embolization 6. any stroke within 1 year after embolization 7. any stroke, death hemorrhagic event, aneurysmal recanalization or retreatment within 1 year after embolization 8. change in aneurysmal occlusion 9. any comlicaion within 1 year after embolization 10. %length of Hydrocoil, maximum diameter of aneurysm, volume embolization ratio

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hydrocoil
Interventions/Control_2	Bare Platinum Coil
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. saccular intracranial aneurysm 2. endovascular treatment scheduled within 60days after consent 3. 20-79 years old 4. unruptured, chronic SAH or acurte SAH Grade 1-III 5. 7-20mm in size 6. 1 year follow up possibel 7. independent (mRS 0-2) 8. document consent
Key exclusion criteria	1. previous endovascular treated 2. additional aneurysm scheduled of endovascular treatment 3. pregnant 4. ineligible for study
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Neurosurgery
Zip code	650-0047
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL	078-302-4321
Email	n.sakai@siren.ocn.ne.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Sakai
Organization	Kobe City Medical Center general Hospital
Division name	Neurosurgery
Zip code	650-0047
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL	078-302-4321
Homepage URL
Email	n.sakai@siren.ocn.ne.jp

Sponsor
Institute	Transitional Research Informatics Center
Institute
Department

Funding Source
Organization	Transitional Research Informatics Center
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe City Medical Center General Hospital
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel	078-302-4321
Email	rinken@kcho.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01516658
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸市立医療センター中央市民病院（兵庫県）、中村記念病院（北海道）、仙台医療センター（宮城県）、広南病院（宮城県）、獨協医科大学越谷病院（埼玉県）、千葉県救命救急センター（千葉県）、千葉大学（千葉県）、虎の門病院（東京都）、東京医科歯科大学（東京都）、新潟大学（新潟県）、富山大学（富山県）、信州大学（長野県）、名古屋大学（愛知県）、岐阜大学（岐阜県）、京都大学（京都府）、大阪大学（大阪府）、国立循環器病研究センター（大阪府）、和歌山労災病院（和歌山県）、岡山大学（岡山県）、山口大学（山口県）、香川大学（香川県）、徳島大学（徳島県）、小倉記念病院（福岡県）、福岡大学（福岡県）、久留米大学（福岡県）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	437
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	not yet reported
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 11 Month 11 Day
Date of IRB	2011 Year 11 Month 20 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2011 Year 11 Month 20 Day
Last modified on	2019 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007977