UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061983 |
|---|---|
| Receipt number | R000070927 |
| Scientific Title | Comparison of 30- and 180-Second Balloon Inflation Durations During Percutaneous Transluminal Angioplasty for Arteriovenous Fistulas: A Prospective Randomized Pilot Trial |
| Date of disclosure of the study information | 2026/06/25 |
| Last modified on | 2026/06/19 23:26:43 |
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Basic information
Public title
A Study Comparing Different Balloon Inflation Durations in Hemodialysis Vascular Access Treatment
Acronym
AVF Balloon Inflation Duration Trial
Scientific Title
Comparison of 30- and 180-Second Balloon Inflation Durations During Percutaneous Transluminal Angioplasty for Arteriovenous Fistulas: A Prospective Randomized Pilot Trial
Scientific Title:Acronym
AVF Balloon Inflation Duration Trial
Region
| Japan |
Condition
Condition
Hemodialysis arteriovenous fistula stenosis
Classification by specialty
| Nephrology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In percutaneous transluminal angioplasty for stenosis of autogenous arteriovenous fistulas used for hemodialysis, the relationship between balloon inflation duration and postprocedural patency has not been fully established. This study aims to randomly compare balloon inflation durations of 30 and 180 seconds and to conduct an exploratory evaluation of the time to reintervention or thrombotic occlusion within 180 days after treatment, as well as procedural outcomes and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to reintervention or thrombotic occlusion within 180 days after treatment.
Key secondary outcomes
The time to reintervention or thrombotic occlusion within 90 days after treatment.
The time to reintervention or thrombotic occlusion within 365 days after treatment.
Technical success at the end of the procedure, defined as residual stenosis of less than 30%; clinical success; and percentage residual stenosis
Adverse events, including dissection, vessel rupture, hematoma, puncture-site complications, and vascular access loss.
Time to target lesion revascularization (TLR) and time to thrombosis of the treated zone through 180 days after treatment
Proportion of lesions with persistent balloon waist, time to complete disappearance of the balloon waist, and inflation pressure at waist disappearance during the initial balloon inflation
Procedure time, fluoroscopy time, hemostasis time after sheath removal, and volume of contrast medium used
Proportion of procedures requiring analgesic or sedative medication, and the type and dose of medication used
Changes in ultrasound parameters from immediately before the procedure to approximately 2 hours after the procedure, including minimum luminal diameter, peak systolic velocity (PSV), PSV ratio, vascular access flow volume (Qa), and resistance index (RI)
Frequency and details of rescue treatment involving additional balloon inflation
Incidence and type of adverse events, including vascular dissection, vessel rupture, hematoma, puncture-site complications, and loss of vascular access
Proportion of eligible procedures for which informed consent for study participation is obtained
Completion rate of the assigned balloon inflation duration, proportion of procedures requiring shortening or discontinuation of the assigned inflation, and reasons for shortening or discontinuation
Completion rate of 180-day follow-up, proportion of missing data, and reasons for censoring or incomplete follow-up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Balloon angioplasty is performed for stenosis of a hemodialysis arteriovenous fistula. Balloon inflation is maintained for 30 seconds after complete disappearance of the balloon waist. If no waist is observed, inflation is maintained for 30 seconds after the prespecified inflation pressure is reached.
Interventions/Control_2
Balloon angioplasty is performed for stenosis of a hemodialysis arteriovenous fistula. Balloon inflation is maintained for 180 seconds after complete disappearance of the balloon waist. If no waist is observed, inflation is maintained for 180 seconds after the prespecified inflation pressure is reached.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adult patients receiving maintenance hemodialysis
2. Patients with an autogenous arteriovenous fistula (AVF)
3. Patients with suspected clinical vascular access dysfunction and stenosis within the vascular access circuit for which percutaneous transluminal angioplasty is considered appropriate by an interventional radiologist
4. Patients who provide written informed consent to participate in the study
Key exclusion criteria
1. Thrombotic occlusion requiring thrombectomy, thrombolysis, or another thrombus-removal procedure
2. Stenosis or occlusion involving the axillary vein or more central veins, including the subclavian vein, brachiocephalic vein, or superior vena cava
3. Patients for whom the operator determines that the use of a cutting balloon or drug-coated balloon is clinically required during the procedure
4. Patients considered unsuitable for participation by the principal investigator because of a severely impaired general condition or other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Norihito |
| Middle name | |
| Last name | Naruto |
Organization
Toyama University Hospital
Division name
Department of Radiology
Zip code
9300152
Address
Sugitani 2630, Toyama, Toyama, Japan
TEL
0764347326
naruto@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Naruto |
Organization
Toyama University Hospital
Division name
Department of Radiology
Zip code
9300152
Address
Sugitani 2630, Toyama, Toyama, Japan
TEL
0764347326
Homepage URL
naruto@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee for Clinical and Epidemiological Research, University of Toyama
Address
Sugitani 2630, Toyama, Toyama, Japan
Tel
0764158857
kenrinri@adm.u-toyama.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 25 | 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
| 2026 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 09 | 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
| 2026 | Year | 06 | Month | 19 | Day |
Last modified on
| 2026 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070927
