UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025228 |
|---|---|
| Receipt number | 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 | 2020/12/15 10:39:57 |
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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 | Wataru |
| Middle name | |
| Last name | Shimizu |
Organization
Nippon medical school hospital
Division name
Department of cardiovascular medicine
Zip code
113-8603
Address
1-1-5 sendagi Bunkyo-ku Tokyo, Japan
TEL
03-3822-2131
wshimizu@nms.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Uwajima |
Organization
Nippon medical school hospital
Division name
General affairs
Zip code
113-8603
Address
1-1-5 sendagi Bunkyo-ku Tokyo, Japan
TEL
03-3822-2131
Homepage URL
youdo@nms.ac.jp
Sponsor or person
Institute
Nippon medical school hospital
Institute
Department
Personal name
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
Center for Clinical Research, Nippon Medical School Hospital
Address
1-1-5 sendagi Bunkyo-ku Tokyo, Japan
Tel
03-3822-2131
clinicaltrial@nms.ac.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
| 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
11
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
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
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
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029012
