UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007365 |
|---|---|
| Receipt number | 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 12:53:46 |
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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
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
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
sdoi@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007771
