UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059132 |
|---|---|
| Receipt number | R000067636 |
| Scientific Title | A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty |
| Date of disclosure of the study information | 2025/09/24 |
| Last modified on | 2025/09/22 15:07:57 |
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Basic information
Public title
A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty
Acronym
A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to DCB angioplasty
Scientific Title
A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty
Scientific Title:Acronym
A randomized clinical trial evaluating the effect of pre-dilatation with a cutting balloon prior to DCB angioplasty
Region
| Japan |
Condition
Condition
End-stage renal disease, hemodialysis vascular access stenosis
Classification by specialty
| Nephrology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients undergoing hemodialysis require reliable vascular access, and the maintenance of arteriovenous:AV access is essential for the continuation of hemodialysis therapy. When AV access stenosis occurs, percutaneous transluminal angioplasty:PTA is the first-line option. Although the clinical success rate of PTA is high, the patency of PTA is relatively low.
Recently, drug coated balloons:DCBs have become available for vascular access stenosis, particularly for patients with early restenosis. Nevertheless, restenosis still occurs in some cases even after DCB angioplasty. In the cardiovascular field, complete lesion preparation prior to DCB deployment often using cutting or scoring balloons is considered critical for optimal outcomes. Such pre dilatation strategies are recommended, yet in the context of vascular access, current treatment guidelines do not specify balloon selection, and supporting evidence remains limited.
Meanwhile, clinical studies on cutting balloons used for AV access stenosis have demonstrated superior dilatation efficacy compared to conventional balloons. If this randomized trial confirms the utility of cutting balloon pre-dilatation prior to DCB use, it may lead to prolonged patency and enhanced therapeutic efficacy of DCBs in vascular access interventions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target legion primary patency rate at 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
intervention: pre-dilatation with a cutting balloon prior to drug-coated balloon angioplasty
Interventions/Control_2
control: pre-dilatation with a conventional balloon prior to drug-coated balloon angioplasty
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
1. Age more than 20 years
2. AV fistula created at least 30 days prior to enrollment
3. At least 8 out of the most recent 12 dialysis sessions were completed without complications
4. Presence of more than 50% stenosis from the anastomosis site to the axillary vein or subclavian vein entry
5. In cases with two stenotic lesions, both must be treatable with a single drug-coated balloon
6. For tandem lesions, the distance between lesions must be within 3 cm
7. Reference vessel diameter at the target lesion must be between 4 mm and 8 mm
8. Written informed consent obtained based on sufficient understanding and voluntary agreement to participate in the study
9. Ability to attend follow up visits after treatment
10. Both de novo and restenotic lesions are eligible for inclusion
Key exclusion criteria
1. Women who are pregnant, breastfeeding, or planning to become pregnant, and men who wish to father children
2. Scheduled to undergo kidney transplantation within 6 months
3. Planned transition to peritoneal dialysis within 6 months
4. Underwent vascular intervention for access within the past 30 days
5. Presence of severe AV access infection or systemic infection contraindicating PTA
6. Scheduled for surgical revision of the AV access within 6 months
7. Presence of secondary lesions requiring additional treatment within 30 days
8. Severe ischemia of the limb contraindicating PTA
9. Presence of advanced malignancy or systemic infection with an expected life expectancy of less than 6 months
10. Moderate to severe vessel tortuosity at the target site that precludes the use of a cutting balloon
11. Presence of visible thrombus at the target lesion that contraindicates the use of a drug coated balloon
12. Presence of a stent at the stenotic site
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | MASAAKI |
| Middle name | |
| Last name | MURAKAMI |
Organization
Shizuoka General Hospital
Division name
Department of Nephrology
Zip code
4208527
Address
4-27-1 Kita-ando, Aoi-ku, Shizuoka, Shizuoka, 420-8527, Japan
TEL
0542476111
mmurakami77207@gmail.com
Public contact
Name of contact person
| 1st name | MASAAKI |
| Middle name | |
| Last name | MURAKAMI |
Organization
Shizuoka General Hospital
Division name
Department of Nephrology
Zip code
4208527
Address
4-27-1 Kita-ando, Aoi-ku, Shizuoka, Shizuoka, 420-8527, Japan
TEL
0542476111
Homepage URL
mmurakami77207@gmail.com
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General 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
Shizuoka General Hospital
Address
4-27-1 Kita-ando, Aoi-ku, Shizuoka, Shizuoka, 420-8527, Japan
Tel
0542476111
chiken-sougou@shizuoka-pho.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
SGHIRB#2025022
Org. issuing International ID_1
Shizuoka General Hospital
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 | 09 | Month | 24 | 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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2031 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067636
