UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of coil embolization of body trunk vascular lesions using Hydrocoils: a multicenter study
Acronym	Coil embolization of body trunk lesions with Hydrocoils: a multicenter study
Scientific Title	Safety and efficacy of coil embolization of body trunk vascular lesions using Hydrocoils: a multicenter study
Scientific Title:Acronym	Coil embolization of body trunk lesions with Hydrocoils: a multicenter study
Region	Japan

Condition
Condition	Body trunk vascular lesions
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the safety and efficacy of coil embolization for body trunk vascular lesion using Hydrocoils in comparison with embolization using bare platinum coils
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Effectiveness i. Embolization effects immedatery after treatment ii. Length of embolized vessel, number of used coils, total length of used coils Safety i. adverse event
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hydrogel-coating coil grou
Interventions/Control_2	Non-hydrogel coating coil group (Bare platinum coil group)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Body trunk vascular lesions which can be treated by coil embolization, including arteriovenous shunt, portosystemic shunt, parent artery occlusion for aneurysm, protective embolization of normal artery, etc. 2. Patients aged 20 or over at the time of informed consent
Key exclusion criteria	1. A case with active bleeding 2. A case with active infective disease 3. A case with active asthma and/or severe allergic disease 4. A case with congestive heart failure 5. A case with blood disease 6. A case with severe hepatic and/or renal disease 7. A case with uncontrollable malignant disease 8. Pregnant 9. A case whose performance status is over 3 10. WBC count is less than 2000 or granulocyte count is less than 1000 11. Platelet count is less than 50,000/mm3 or PT-INR is over 1.5 12. A case deemed to be inadequate for this study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hiro Middle name Last name Kiyosue
Organization	Oita University Faculty of Medicine
Division name	Radiology
Zip code	879-5593
Address	Idaigaoka, 1-1, Hasama-machi, Yufu-shi, Oita
TEL	097-586-5934
Email	hkiyosue@oita-u.ac.jp

Public contact
Name of contact person	1st name Shuichi Middle name Last name Tanoue
Organization	Oita University Faculty of Medicine
Division name	Radiology
Zip code	879-5593
Address	Idaigaoka, 1-1, Hasama-machi, Yufu-shi, Oita
TEL	097-586-5934
Homepage URL
Email	stanoue@oita-u.ac.jp

Sponsor
Institute	Department of Radiology, Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization	Department of Radiology, Oita University Faculty of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	General Clinical Research Center, Oita University Hospital
Address	1-1, Idaigaoka, Hasama-machi, Yufu, Oita
Tel	097-586-6163
Email	gcrcjimu@oita-u.ac.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	大分大学，慶応大学，大阪大学，奈良県立医科大学，久留米大学

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	77
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	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
Date of IRB	2016 Year 07 Month 27 Day
Anticipated trial start date	2013 Year 08 Month 31 Day
Last follow-up date	2020 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 01 Day
Last modified on	2021 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013587