UMIN-CTR Clinical Trial

Basic information
Public title	Prospective registry trial of pre-surgical embolization for brain arteriovenous malformation using PHIL
Acronym	Prospective registry trial of pre-surgical embolization for brain AVM using PHIL
Scientific Title	Multi-center, single arm, prospective registry trial of pre-surgical embolization for brain arteriovenous malformation using PHIL (PH-112)
Scientific Title:Acronym	Prospective registry trial of pre-surgical embolization for brain AVM using PHIL (PH-112)
Region	Japan

Condition
Condition	brain arteriovenous malformation
Classification by specialty	Radiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm safety and efficacy of pre-surgical embolization of brain arteriovenous malformation using PHIL
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	50% or more volume reduction by embolization and no mortality within 30days after surgical resection
Key secondary outcomes	1. bleeding volume during surgical resection 2. duration of surgical resection 3. severe adverse event related to embolization 4. all mortality within 30days after embolization 5. all stroke within 30days after embolization 6. neurological deterioration within 30days after embolization 7. modified Rankin Scale 30days after embolization surgical resection

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	pre-surgical endovascular embolization using PHIL
Interventions/Control_2
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. brain arteriovenous malformation 2. indicated to surgical resection 3. 4 or less of modified Rankin Scale 4. 1 to 4 of Spetzler & Martin Grade 5. exist feeding artery candidate to trans-arterial embolization 6. obtain documented consent form
Key exclusion criteria	1. impossible to use heparin 2. history of severe alergic reaction to contrast media 3. impossible to navigate microcatheter to ideal position 4. intolelance to provocative test 5. no distal flow by vasospasm 6. liver dysfunction (AST 120U or larger) or renal dysfunction (CRTN 2.0mg/dL or larger) 7. history of embolization using non-adhesive liquid material for target brain AVM 8. candidate to another approving trial 9. pregnant or possible to pregnancy lady 10. inappropriate patient for this trial
Target sample size	40

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, Japan
TEL	078-302-4321
Email	n.sakai@siren.ocn.ne.jp

Public contact
Name of contact person	1st name Chiaki Middle name Last name Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Center for Clinical Research and Innovation
Zip code	650-0047
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL	078-302-4321
Homepage URL
Email	chiakimk@cronos.ocn.ne.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	Terumo Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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, Japan
Tel	078-302-4321
Email	chiken@kcho.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	広南病院、筑波大学、埼玉医科大学国際医療センター、順天堂大学、昭和大学藤が丘病院、富山大学、名古屋大学、京都大学、大阪医療センター、兵庫医科大学、神戸市立医療センター中央市民病院、岡山大学

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 16 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	Enrolling by invitation
Date of protocol fixation	2019 Year 09 Month 24 Day
Date of IRB	2019 Year 09 Month 24 Day
Anticipated trial start date	2019 Year 10 Month 16 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 16 Day
Last modified on	2019 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043658