UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010109 |
|---|---|
| Receipt number | R000011845 |
| Scientific Title | Verify the efficacy of renal artery stenting to define the predictors of ischemic constriction via pressure gradient |
| Date of disclosure of the study information | 2013/02/25 |
| Last modified on | 2020/09/03 16:49:19 |
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Basic information
Public title
Verify the efficacy of renal artery stenting to define the predictors of ischemic constriction via pressure gradient
Acronym
VERDICT trial
Scientific Title
Verify the efficacy of renal artery stenting to define the predictors of ischemic constriction via pressure gradient
Scientific Title:Acronym
VERDICT trial
Region
| Japan |
Condition
Condition
Hypertension and/or renal dysfunction due to atherosclerotic renal artery stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the Efficacy of Renal artery stenting to Define the predictors of Ischemic Constriction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Predictor of therapeutic effect of the treatment group showed a variation in response of hypertension and/or renal function
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The atherosclerotic renal artery stenosis(ARAS) patients with
1: more than 145 or over mmHg systolic blood pressure at any time,or 135 mmHg or over in 24-hourABPM average systolic blood pressure
And or /
2: CKD patients eGFR<60ml/min/1.73m2 (over CKD stage 3)
ARAS is defined with more than RAR3.5 and PSV219cm/sec in duplexrenal artery echo
Key exclusion criteria
The patients of
end stage renal dysfunction on hemodialysis
Fibromuscular Dysplasia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Yokoi |
Organization
Kishiwada Tokushukai Hospital
Division name
Cardiology
Zip code
Address
4-27-1 Kamori-cho,Kishiwada-city Osaka,Japan
TEL
072-445-9915
masahiko-fujihara@themis.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Shimogama |
Organization
VERDICT trial secretariat
Division name
VERDICT trial secretariat
Zip code
Address
3-2-1 Asano kokura kita-ku,kitakyushuu City. Fukuoka,Japan
TEL
093-967-8680
Homepage URL
verdict@j-et.jp
Sponsor or person
Institute
Kishiwada Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Endovascular treatment conference
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 02 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In progress
Management information
Registered date
| 2013 | Year | 02 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011845
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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