UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056288 |
|---|---|
| Receipt number | R000064316 |
| Scientific Title | Efficacy of drug-coated balloon for repeated short-term restenosis of dialysis arteriovenous fistulas |
| Date of disclosure of the study information | 2024/11/28 |
| Last modified on | 2024/11/28 11:41:56 |
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Basic information
Public title
Efficacy of drug-coated balloon for repeated short-term restenosis of dialysis
arteriovenous fistulas
Acronym
Efficacy of drug-coated balloon for repeated short-term restenosis of dialysis
arteriovenous fistulas
Scientific Title
Efficacy of drug-coated balloon for repeated short-term restenosis of dialysis
arteriovenous fistulas
Scientific Title:Acronym
Efficacy of drug-coated balloon for repeated short-term restenosis of dialysis
arteriovenous fistulas
Region
| Japan |
Condition
Condition
Patients with end-stage renal disease (ESRD) undergoing maintenance dialysis
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement in patency outcomes after catheter-based treatment for stenosis in arteriovenous fistula(AVF)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patency outcomes after catheter-based treatment until restenosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 45 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We enrolled 50 consecutive patients who suffered two consecutive restenosis within 6 months of each other after VAIVT with a standard balloon.
Key exclusion criteria
A shunt created in the lower limb or using an arteriovenous graft (AVG) for maintenance dialysis purposes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
6560021
Address
1-1-137 Shioya, Sumoto City, Hyogo Prefecture, Japan
TEL
0799221200
k722black@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Maeda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
6560021
Address
1-1-137 Shioya, Sumoto City, Hyogo Prefecture, Japan
TEL
0799221200
Homepage URL
maeda.takanori.tokushima@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Awaji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Prefectural Awaji Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Prefectural Awaji Medical Center
Address
1-1-137 Shioya, Sumoto City, Hyogo Prefecture, Japan
Tel
0799221200
maeda.takanori.tokushima@gmail.com
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
| 2024 | Year | 11 | Month | 28 | 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
50
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is single-center, retrospective study. We enrolled 50 consecutive patients who suffered two consecutive restenosis within 6 months of each other after VAIVT with a standard balloon. In the third VAIVT procedures, they were treated with DCB or standard balloon. Target lesion revascularization (TLR) was evaluated at a mean 11.5 months after the third VAIVT.
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064316
