UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021502 |
|---|---|
| Receipt number | R000024799 |
| Scientific Title | Clinical evaluation of newly developed, optical-fiber based FFR device, comparing with conventional FFR devise using piezo electric sensors. |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2017/09/17 10:10:48 |
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Basic information
Public title
Clinical evaluation of newly developed, optical-fiber based FFR device, comparing with conventional FFR devise using piezo electric sensors.
Acronym
Clinical evaluation of optical-fiber based FFR device
Scientific Title
Clinical evaluation of newly developed, optical-fiber based FFR device, comparing with conventional FFR devise using piezo electric sensors.
Scientific Title:Acronym
Clinical evaluation of optical-fiber based FFR device
Region
| Japan |
Condition
Condition
coronary artery disease patients
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
clinical evaluation of efficacy and safety of optical-fiber basedFFR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Evaluation of Safety use of newly FFR devise
2. Evaluation of Fractional Flow Reserve
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
1) intermediate coronary stenosis
2) more than 20 years old
Key exclusion criteria
1) AV block
2) bronchial athma
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ishii |
Organization
Nagoya University Graduate School of Medicine
Division name
cardiology
Zip code
Address
65 Tsurumai-cho, showa-ku, Nagoya,Japan
TEL
0527442147
susumusuzuki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Suzuki |
Organization
Nagoya University Graduate School of Medicine
Division name
Cardiology
Zip code
Address
65 Tsurumai-cho, showa-ku, Nagoya,Japan
TEL
0527442147
Homepage URL
susumusuzuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
zeon medical
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 03 | Month | 16 | 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
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patients with intermediate coronary stenosis
Management information
Registered date
| 2016 | Year | 03 | Month | 16 | Day |
Last modified on
| 2017 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024799
