UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007365
Receipt No. R000007771
Scientific Title Effect of high-pressure balloon angioplasty on patency rate at one year in hemodialysis patients with auto-vascular access stenosis
Date of disclosure of the study information 2012/02/23
Last modified on 2019/04/18 (Ver. 9)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title Effect of high-pressure balloon angioplasty on patency rate at one year in hemodialysis patients with auto-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 auto-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 auto-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 Brescia-cimino fistula 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 130

Research contact person
Last 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
1st 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 None
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

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

Related information
URL releasing protocol https://journals.sagepub.com/doi/full/10.1177/1129729818760976?url_ver=Z39.88-2003&rfr_id=ori%3Arid%
Publication of results Published

Result
URL related to results and publications https://journals.sagepub.com/doi/full/10.1177/1129729818760976?url_ver=Z39.88-2003&rfr_id=ori%3Arid%
Number of participants that the trial has enrolled 71
Results 
The 12-month patency rates showed no significant difference between the low- and high-pressure groups. In the low-pressure group, the patency rate was not different between patients with complete dilation and residual stenosis. The Cox proportional hazard model revealed that the 12-month patency rate was associated with the stenosis diameter and the presence of diabetes.
Results date posted
2019 Year 04 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
After written informed consent was obtained, the patients were assigned into the low- or high-pressure group (dilation at 8 atm or 30 atm, respectively) according to the allocation table, taking sex and the presence of diabetes mellitus into consideration.
Participant flow 
Patency period was defined as a term from PTA to next PTA or surgical revision. In addition to age and presence of diabetes mellitus, we collected the data of the location, diameters of stenosis site, its proximal and distal veins, and length of stenosis. We also investigated presence complicate dilation, pressure when achieved complete dilation, and an incidence of complication.
Adverse events 
No
Outcome measures 
The 12 months patency rate between the low and high pressure groups were compared by Kaplan-Meier method, following log-rank test. Similarly, in the low-pressure group, the 12-months patency rate between patients with complete dilation and those with incomplete dilation. Cox proportional hazard analyses were performed to identify factors which are independently associated with the 12 months patency. Analyses were performed using SPSS software.
Plan to share IPD No
IPD sharing Plan description No

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 05 Month 11 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

Management information
Registered date
2012 Year 02 Month 23 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007771