UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Acronym	Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Scientific Title	Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Scientific Title:Acronym	Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Region	Japan

Condition
Condition	Hemodialysis vascular access stenosis
Classification by specialty	Cardiology Nephrology Urology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and the efficacy of peripheral cutting balloon compared with conventional balloon for angioplasty of hemodialysis stenotic vascular access
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	6-month primary patency rate
Key secondary outcomes	Duration of primary patency of the hemodialysis vascular access (Treatment area primary patency and access circuit primary patency) Complication Anatomical success Clinical success Procedural success Ultrasonographic finding before and after PTA(Percutaneous transluminal angioplasty) Subjective assessment of pain during balloon-cathether inflation Ultrasonographic finding at 3 months and 6 months after the intervention Angiography at 6 months

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	PTA(Percutaneous transluminal angioplasty)
Interventions/Control_2	Peripheral Cutting Balloon
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.Patient receiving hemodialysis for end stage renal disease with stenotic hemodialysis fistura or graft located on the upper extremities 2.Patient has stenotic vascular access necessary for PTA within 6 months after either surgical procedure or PTA for the stenotic lesion (PTA is indicated when vascular access stenosis is >= 50% and at least one of the clinical or physiological abnormalities are recognized) 3.PTA thought by the investigator to be the best treatment choice 4.Patient capable of providing written informed consent 5.Reference vessel for the targeted stenotic lesion with the diameter of >=3mm and <=6.5mm 6.Hemodialysis vascular access constructed more than 30 days prior to enrollment
Key exclusion criteria	1.Patient incapable of providing written informed consent 2.Life expectancy <6 months 3.Severe allergy to contrast medium 4.Active vascular access infection 5.Pregnancy 6.A Stent placed at the target lesion 7.An angulation of target lesion >=45 degrees 8.The reference vessel diameter <2mm 9.The target stenosis >20mm in length 10.Total occlusion 11.Severe calcification of target lesion 12.Junctional lesion needed for double guide-wire technique 13.Target lesion with branches unable to protect 14.Severely tortuous vessel proximal to the lesion 15.Multiple stenotic lesion needed for multiple sheath insertion
Target sample size	374

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Murakami
Organization	Shizuoka General Hospital
Division name	Department of Nephrology
Zip code	420-8527
Address	Shizuoka
TEL	054-247-6111
Email	mmurakami77207@gmail.com

Public contact
Name of contact person	1st name Masaaki Middle name Last name Murakami
Organization	Shizuoka General Hospital
Division name	Department of Nephrology
Zip code	420-8527
Address	Shizuoka
TEL	054-247-6111
Homepage URL
Email	mmurakami77207@gmail.com

Sponsor
Institute	Shizuoka General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shizuoka General Hospital
Address	4-27-1 Kitaando, Aoiku, Shizuoka, Shizuoka
Tel	0542476111
Email	momoko-maejima@shizuoka-pho.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	2012 Year 12 Month 15 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	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 01 Day
Date of IRB	2012 Year 11 Month 20 Day
Anticipated trial start date	2012 Year 12 Month 17 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 15 Day
Last modified on	2021 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011207