UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048604 |
|---|---|
| Receipt number | R000055386 |
| Scientific Title | Feasibility of Radial Artery Access in the Field of Interventional Radiology |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2025/02/05 09:45:31 |
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Basic information
Public title
Feasibility of Radial Artery Access in the Field of Interventional Radiology
Acronym
RAVI study
Scientific Title
Feasibility of Radial Artery Access in the Field of Interventional Radiology
Scientific Title:Acronym
RAVI study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma, Liver Metastases
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to prospectively examine the procedure of interventional radiology with radial artery access, whether the procedure can be performed without problems, to identify problems, and to make improvements.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate of the interventional radiology procedure via radial artery or distal radial artery
Key secondary outcomes
Search for risk factors affecting procedure completion
Search for factors affecting procedure time
Difficulty of radial artery puncture
Analysis of patient opinions related to nursing care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients scheduled to undergo interventional radiology considered suitable for radial artery access
(2)Patients who are 20 years of age or older at the time of consent
(3)Patients who have fully understood their participation in this study and have given their free and voluntary written consent.
Key exclusion criteria
(1) Patients who have been enrolled in this study (RAVI trial) in the past
(2)Patients who are unable to answer the questionnaire due to dementia or other reasons
(3)Patients who are considered unsuitable for left radial artery puncture
(4)Patients with a left radial artery diameter of less than 2 mm
(5)Patients who are considered to have insufficient development of the left palmar artery arch
(6)Patients who are deemed inappropriate to participate in this study by the physician in charge.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kodama |
Organization
Teine Keijinkai Hospital
Division name
Department of Radiology
Zip code
006-8555
Address
1-12-1-40 Maeda Teineku Sapporo
TEL
011-681-8111
ykodama@mud.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Kodama |
Organization
Teine Keijinkai Hospital
Division name
Department of Radiology
Zip code
006-8555
Address
1-12-1-40 Maeda Teineku Sapporo
TEL
011-681-8111
Homepage URL
ykodama@mud.biglobe.ne.jp
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
Teine Keijinkai 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
Teine Keijinkai Hospital
Address
1-12-1-40 Maeda Teineku Sapporo
Tel
011-681-8111
tkh-rinriml@keijinkai.or.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
手稲渓仁会病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Items
Patient background (age, gender, comorbidities, medical history, background diseases, reason for Interventional radiology application, presence of antithrombotic drugs, radial/distal radial artery diameter, evaluation of palmar artery arch)
Puncture mode (distal radial, radial, inguinal)
Success rate of puncture, years of experience of the surgeon, whether there was a change of surgeon, learning curve of the surgeon
Time-out time, time to sheath insertion, time for subaortic arch access, time to reach target vessel of parent catheter, sheath removal time
Presence of radial artery occlusion, extent of hematoma, patient survey (next day), presence of CTCAE v5.0 Grade 3 or higher adverse events (up to 1 month after procedure)
Management information
Registered date
| 2022 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055386
