UMIN-CTR Clinical Trial

Basic information
Public title	Effect of high-pressure balloon angioplasty on patency rate at one year in hemodialysis patients with synthetic graft-vascular access stenosis
Acronym	High pressure angioplasty and patency rate
Scientific Title	Effect of high-pressure balloon angioplasty on patency rate at one year in hemodialysis patients with synthetic graft-vascular access stenosis
Scientific Title:Acronym	High pressure angioplasty and patency rate
Region	Japan

Condition
Condition	Vascular access stenosis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify whether high pressure balloon angioplasty for synthetic graft-vascular access stenosis is effective on a patency rate.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The 1-year patency rate after balloon angioplasty
Key secondary outcomes	Primary success rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
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	Maneuver
Interventions/Control_1	Balloons are inflated to the pressure of 8 atm (low pressure group) or 30 atm (high pressure group)
Interventions/Control_2	In the case of restenosis the balloon size will be increased by 1 mm and the balloon inflated with same pressure range as the initial treatment
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	Patients who underwent vascular access failure in forearm loop graft, and satisfy the indication criteria for PTA established by the Japanese Society for Dialysis Therapy. All patients are treated with PTA for the first time.
Key exclusion criteria	Patients who underwent PTA before
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name MASAKI
Organization	Hiroshima University Hospital
Division name	Department of Nephrology
Zip code	734-8551
Address	1-2-3 Kasumi Minami-ku, Hiroshima,
TEL	082-257-1506
Email	masakit@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Shigehiro Middle name Last name DOI
Organization	Hiroshima University Hospital
Division name	Department of Blood Purification
Zip code	734-8551
Address	1-2-3 Kasumi Minami-ku, Hiroshima,
TEL	082-257-5960
Homepage URL
Email	sdoi@hiroshima-u.ac.jp

Sponsor
Institute	Department of Nephrology, Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	No
Name of secondary funder(s)	No

IRB Contact (For public release)
Organization	Hiroshima University Hospital
Address	1-2-3 Kasumi Minamiku, Hiroshima
Tel	082-257-5555
Email	hugcp@hiroshima-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	広島大学病院(広島県)、尾道クリニック(広島県)、尾道総合病院（広島県）、中央内科クリニック(広島県)、呉共済病院(広島県)、呉医療センター(広島県)、博愛クリニック（広島県）、県立広島病院（広島県）、一陽会原田病院(広島県)、広島西医療センター（広島県）、あかね会土谷総合病院(広島県)

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 23 Day

Related information
URL releasing protocol	http://jinzounaika.hiroshima-u.ac.jp/
Publication of results	Unpublished

Result
URL related to results and publications	http://jinzounaika.hiroshima-u.ac.jp/
Number of participants that the trial has enrolled	0
Results	withdrowal
Results date posted	2019 Year 04 Month 18 Day
Results Delayed
Results Delay Reason	difficlt to obtain samples
Date of the first journal publication of results
Baseline Characteristics	withdrowal
Participant flow	withdrowal
Adverse events	No
Outcome measures	withdrowal
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 05 Month 26 Day
Date of IRB	2001 Year 10 Month 20 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2016 Year 11 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 01 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2016 Year 12 Month 01 Day

Other
Other related information	withdrowal

Management information
Registered date	2012 Year 02 Month 23 Day
Last modified on	2021 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007772