UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048439 |
|---|---|
| Receipt number | R000054910 |
| Scientific Title | Single-center observational study on the efficacy and safety of drug-coated balloons for vascular access intervention therapy |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/07/23 09:47:03 |
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Basic information
Public title
observational study on the efficacy and safety of drug-coated balloons for dialysis arteriovenous fistula
Acronym
observational study of drug-coated balloons for dialysis arteriovenous fistula
Scientific Title
Single-center observational study on the efficacy and safety of drug-coated balloons for vascular access intervention therapy
Scientific Title:Acronym
Single-center observational study of drug-coated balloons for vascular access intervention therapy
Region
| Japan |
Condition
Condition
Dysfunctional dialysis arteriovenous fistula
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The rate of restenosis after balloon treatment is high for shunt stenosis during dialysis, and the effect of drug-coated balloons on preventing restenosis should be observed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
dialysis shunt patency rate after 6 months
Key secondary outcomes
Adverse event incidence
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
An example of satisfying the following situation of dialysis shunt
1) Restenosis cases
2) Stenosis rate 50% or more and lesion length 10 cm or less
3) Pre-balloon dilatation results in less than 30% residual stenosis and no serious dissection
4) No other prioritized treatment
Key exclusion criteria
Those who have offered to refuse participation
Those who are judged to be inappropriate as research subjects
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Matsumoto |
Organization
Nihon University Hospital
Division name
Cardiology
Zip code
101-8309
Address
1-6 Surugadai kanda chiyoda-ku, Tokyo
TEL
0332931711
matsumoto.michiaki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiaki |
| Middle name | |
| Last name | Matsumoto |
Organization
Nihon University Hospital
Division name
Cardiology
Zip code
101-8309
Address
1-6 Surugadai kanda chiyoda-ku, Tokyo
TEL
0332931711
Homepage URL
matsumoto.michiaki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Hospital
Address
1-6 Surugadai kanda chiyoda-ku, Tokyo
Tel
0332931711
matsumoto.michiaki@nihon-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
日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registry of routine clinical catheter treatment for dialysis shunt treatment. The primary endpoint is the shunt patency rate after 6 months.
Management information
Registered date
| 2022 | Year | 07 | Month | 23 | Day |
Last modified on
| 2022 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054910
