UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009556 |
|---|---|
| Receipt number | R000011207 |
| Scientific Title | Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~ |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2021/06/21 16:00:33 |
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Basic information
Public title
Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Acronym
Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Scientific Title
Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Scientific Title:Acronym
Comparison of peripheral cutting balloon versus conventional balloon angioplasty for hemodialysis vascular access stenosis ~prospective randomized controlled trial~
Region
| Japan |
Condition
Condition
Hemodialysis vascular access stenosis
Classification by specialty
| Cardiology | Nephrology | Urology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and the efficacy of peripheral cutting balloon compared with conventional balloon for angioplasty of hemodialysis stenotic vascular access
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
6-month primary patency rate
Key secondary outcomes
Duration of primary patency of the hemodialysis vascular access
(Treatment area primary patency and access circuit primary patency)
Complication
Anatomical success
Clinical success
Procedural success
Ultrasonographic finding before and after PTA(Percutaneous transluminal angioplasty)
Subjective assessment of pain during balloon-cathether inflation
Ultrasonographic finding
at 3 months and 6 months after the intervention
Angiography at 6 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
PTA(Percutaneous transluminal angioplasty)
Interventions/Control_2
Peripheral Cutting Balloon
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.Patient receiving hemodialysis for end stage renal disease with stenotic hemodialysis fistura or graft located on the upper extremities
2.Patient has stenotic vascular access necessary for PTA within 6 months after either surgical procedure or PTA for the stenotic lesion (PTA is indicated when vascular access stenosis is >= 50% and at least one of the clinical or physiological abnormalities are recognized)
3.PTA thought by the investigator to be the best treatment choice
4.Patient capable of providing written informed consent
5.Reference vessel for the targeted stenotic lesion with the diameter of >=3mm and <=6.5mm
6.Hemodialysis vascular access constructed more than 30 days prior to enrollment
Key exclusion criteria
1.Patient incapable of providing written informed consent
2.Life expectancy <6 months
3.Severe allergy to contrast medium
4.Active vascular access infection
5.Pregnancy
6.A Stent placed at the target lesion
7.An angulation of target lesion >=45 degrees
8.The reference vessel diameter <2mm
9.The target stenosis >20mm in length
10.Total occlusion
11.Severe calcification of target lesion
12.Junctional lesion needed for double guide-wire technique
13.Target lesion with branches unable to protect
14.Severely tortuous vessel proximal to the lesion
15.Multiple stenotic lesion needed for multiple sheath insertion
Target sample size
374
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
420-8527
Address
Shizuoka
TEL
054-247-6111
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
420-8527
Address
Shizuoka
TEL
054-247-6111
Homepage URL
mmurakami77207@gmail.com
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Shizuoka
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka General Hospital
Address
4-27-1 Kitaando, Aoiku, Shizuoka, Shizuoka
Tel
0542476111
momoko-maejima@shizuoka-pho.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
| 2012 | Year | 12 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 11 | 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
| 2012 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011207
