UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057583 |
|---|---|
| Receipt number | R000065581 |
| Scientific Title | A Comparison of Patency Rates Based on Balloon Selection in PTA (percutaneous transluminal angioplasty) for CAS (Cephalic Arch Stenosis) in AVFs (Arteriovenous Fistulas) for Hemodialysis |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2026/08/02 02:45:16 |
* 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
A Comparison of Patency Rates Based on Balloon Selection in PTA (percutaneous transluminal angioplasty) for CAS (Cephalic Arch Stenosis) in AVFs (Arteriovenous Fistulas) for Hemodialysis
Acronym
Comparison of patency of different balloons in PTA (percutaneous transluminal angioplasty) for stenosis at the cephalic arch of AVF (arteriovenous fistula) for hemodialysis
Scientific Title
A Comparison of Patency Rates Based on Balloon Selection in PTA (percutaneous transluminal angioplasty) for CAS (Cephalic Arch Stenosis) in AVFs (Arteriovenous Fistulas) for Hemodialysis
Scientific Title:Acronym
A Comparison of Patency Rates Based on Balloon Selection in PTA (percutaneous transluminal angioplasty) for CAS (Cephalic Arch Stenosis) in AVFs (Arteriovenous Fistulas) for Hemodialysis
Region
| Japan |
Condition
Condition
stenosis at the cephalic arch in AVF for hemodialysis
Classification by specialty
| Nephrology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the impact of the balloons on patency in PTA cases for cephalic arch lesions at our institution and affiliated institutions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
This study compared the duration of lesion patency among hemodialysis patients who underwent PTA for CAS, grouping them into a non-compliance balloon (NCB) group, a drug-coated balloon (DCB) group, and a peripheral cutting balloon (PCB) group based on the devices used.
Key secondary outcomes
As secondary endpoints, we evaluated the primary patency rates at the lesion site at 90 and 180 days postoperatively. We also examined the factors that influenced the patency rate at 120 days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following are the guidelines for PTA: vascular diameter of the shoulder radial vein is less than 2.5 mm, brachial artery blood flow is less than 400 ml/min, and RI is greater than 0.60. Other clinical symptoms include prolonged hemostasis time during dialysis of 20 minutes or more, elevated venous pressure of 180 mmHg or more, or enlarged shunt varices or elevated shunt pressure on examination. PTA was indicated when clinical symptoms included prolonged hemostatic time on dialysis of 20 minutes or more, elevated venous pressure of 180 mmHg or more, or enlarged shunt varices or elevated shunt pressure on examination.
Key exclusion criteria
Patients will be excluded from the study if they meet any of the following criteria
1.Patients who underwent stenting during PTA
2.Cases in which the patient died or did not receive medical attention and the progress could not be confirmed
3.Other patients who were judged to be inappropriate for inclusion in the study by the physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama medical university
Division name
Nephrology
Zip code
350-0495
Address
38, Moro Hongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
0492761611
tatkondo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Kondo |
Organization
Saitama medical university
Division name
Nephrology
Zip code
350-0495
Address
38, Moro Hongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
0492761611
Homepage URL
tatkondo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Hirokazu Okada
Funding Source
Organization
Saitama medical university
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
Saitama medical university IRB
Address
38, Moro Hongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
0492761111
s_ccr@saitama-med.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
| 2025 | Year | 06 | 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
86
Results
Of the 86 patients who underwent PTA for CAS within the study period, 84 were included in the analysis. The devices used for treatment were NCB in 45 cases, DCB in 20 cases, and PCB in 19 cases.
The median duration of lesion patency was 115 [94, 166] days overall (NCB group: DCB group: PCB group = 119 days: 114 days: 100 days (p=0.103)), and no significant differences were observed between the groups.
Results date posted
| 2026 | Year | 08 | Month | 02 | Day |
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study, backward-looking cohort study
Management information
Registered date
| 2025 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065581
