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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010109
Receipt No. 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

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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
Email 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
Email verdict@j-et.jp

Sponsor
Institute Kishiwada Tokushukai Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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