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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025228
Receipt No. R000029012
Scientific Title Application of vascular flow reserve to evaluate ischemic severity of peripheral arterial disease.
Date of disclosure of the study information 2016/12/13
Last modified on 2016/12/12

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Basic information
Public title Application of vascular flow reserve to evaluate ischemic severity of peripheral arterial disease.
Acronym Vascular flow reserve for the evaluation of peripheral arterial disease.
Scientific Title Application of vascular flow reserve to evaluate ischemic severity of peripheral arterial disease.
Scientific Title:Acronym Vascular flow reserve for the evaluation of peripheral arterial disease.
Region
Japan

Condition
Condition Peripheral arterial disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to evaluate the vascular flow reserve as a novel method for the measurement of ischemic severity in peripheral arterial disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the relationship between vascular flow reserve and SPP, TcPO2, severity of stenosis in angiography, and degree of ischemic ulcer.
Key secondary outcomes Evaluation of one-year prognosis based on a vascular flow reserve in the patient with peripheral arterial disease

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Vascular flow reserve is measured at the time of angiography or angioplasty in the patient with peripheral arterial disease.
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 patient with peripheral arterial disease who are scheduled angiography or angioplasty.
Key exclusion criteria The patients with atrial flatter or atrial fibrillation.
The patients who have residual stenosis at iliac artery, femoral artery, popliteal artery.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Shimizu
Organization Nippon medical school hospital
Division name Department of cardiovascular medicine
Zip code
Address 1-1-5 sendagi Bunkyo-ku Tokyo, Japan
TEL 03-3822-2131
Email wshimizu@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Uwajima
Organization Nippon medical school hospital
Division name General affairs
Zip code
Address 1-1-5 sendagi Bunkyo-ku Tokyo, Japan
TEL 03-3822-2131
Homepage URL
Email youdo@nms.ac.jp

Sponsor
Institute Nippon medical school hospital
Institute
Department

Funding Source
Organization Mitsukoshi health and welfare foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2016 Year 12 Month 13 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
2016 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029012

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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