UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055455 |
|---|---|
| Receipt number | R000063367 |
| Scientific Title | Feasibility and safety of the distal radial access for vascular access interventional therapy |
| Date of disclosure of the study information | 2024/09/09 |
| Last modified on | 2024/09/07 20:00:59 |
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Basic information
Public title
Feasibility and safety of the distal radial access for vascular access interventional therapy
Acronym
Feasibility and safety of the distal radial access for vascular access interventional therapy
Scientific Title
Feasibility and safety of the distal radial access for vascular access interventional therapy
Scientific Title:Acronym
Feasibility and safety of the distal radial access for vascular access interventional therapy
Region
| Japan |
Condition
Condition
Dysfunction of arteriovenous fistulas
Classification by specialty
| Cardiology | Nephrology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
he number of maintenance haemodialysis patients in Japan continues to rise, with a corresponding increase in shunt vascular access intervention therapy (VAIVT) for shunt vessel stenosis or obstruction. The shunt vessel or brachial artery has been used, but there is a risk of haemorrhagic complications during haemostasis when a sheath with a large diameter is inserted. In coronary angiography and percutaneous coronary intervention, the distal radial artery has recently been used as an approach site less prone to postoperative vascular occlusion and haemorrhagic complications. However, no studies have examined the efficacy and safety of the distal radial artery as an approach site for VAIVT.
The aim of this study was to observe, investigate and clarify the efficacy and safety of the distal radial artery as an approach site during VAIVT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of VAIVT techniques
Hand technique complications (haemorrhagic complications, finger hyperemia)
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Maintenance haemodialysis patients who underwent VAIVT for shunt vessels created in the upper limb between January 2020 and December 2023
Key exclusion criteria
Patients with shunts created outside the upper arm
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
TEL
09039981922
k722black@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kuroda |
Organization
Hyogo Prefectural Awaji Medical Center
Division name
Department of Cardiology
Zip code
656-0021
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
TEL
09039981922
Homepage URL
k722black@yahoo.co.jp
Sponsor or person
Institute
Hyogo Prefectural Awaji Medical Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Prefectural Awaji Medical Center, Department of Cardiology
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
Hyogo Prefectural Awaji Medical Center
Address
1-1-137 Shioya, Sumoto, Hyogo 656-0021, Japan
Tel
0799-22-1200
Awaji_hos@pref.hyogo.lg.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
| 2024 | Year | 09 | Month | 09 | 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
421
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Maintenance haemodialysis patients who underwent VAIVT on shunt vessels created in the upper limb at Hyogo Awaji Medical Centre during the period covered by this study (1 January 2020 to 31 December 2023) will be studied retrospectively. After the study, the primary outcome will be compared with the usual approach sites (shunt vessel and brachial artery).
Management information
Registered date
| 2024 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063367
