UMIN-CTR Clinical Trial

Basic information
Public title	Prospective registry trial of trans-arterial embolization for dural arteriovenous fistula using PHIL
Acronym	Prospective registry trial of trans-arterial embolization for dAVF using PHIL
Scientific Title	Multi-center, single arm, prospective registry trial of transs-arterial embolization for dural arteriovenous fistula using PHIL (PH-112)
Scientific Title:Acronym	Prospective registry trial of trans-arterial embolization for dAVF using PHIL (PH-112)
Region	Japan

Condition
Condition	dural arteriovenous fistula
Classification by specialty	Radiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm safety and efficacy of trans-arterial embolization of dural arteriovenous fistula using PHIL
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	curative occlusion at 180 days after embolization and no pprocedure related mortality, stroke and severe hemorrhagic event within 30days after surgical resection
Key secondary outcomes	1. recanalization at 180 days after embolization 2. re-treatment related to recanalization at 180 days after embolization 3. neurological symptoms related to recanalization at 180 days after embolization 4. any death at 180 days after embolization 5. any stroke at 180 days after embolization 6, neurological deterioration at 180 days after embolization 7. modified Rankin Scale at 180 days after embolization

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	trans-arterial 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. dural arteriovenous fistula 2. difficult to cure with trans-venous embolization 3. 4 or less of modified Rankin Scale 4. exist feeding artery candidate to trans-arteri al embolization 5. 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 idea l position 4. intolelance to provocative test 5. no distal flow by vasospasm 6. liver dysfunction (AST 120U or larger) or re nal dysfunction (CRTN 2.0mg/dL or larger) 7. history of embolization using non-adhesive li quid 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	22

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, 650-0047 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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 18 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 20 Day
Last follow-up date	2021 Year 03 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 18 Day
Last modified on	2019 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043668