UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028268 |
|---|---|
| Receipt number | R000032228 |
| Scientific Title | Clinical comparison study between newly developed FFR device based on optical interferometry and conventional FFR device |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/02/03 10:51:38 |
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Basic information
Public title
Clinical comparison study between newly developed FFR device based on optical interferometry and conventional FFR device
Acronym
Clinical evaluation study with FFR device based on optical interferometer
Scientific Title
Clinical comparison study between newly developed FFR device based on optical interferometry and conventional FFR device
Scientific Title:Acronym
Clinical evaluation study with FFR device based on optical interferometer
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 based FFR
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 asthma
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Amano |
Organization
Aichi Medical University
Division name
cardiology
Zip code
4801195
Address
1-1 Yazakokarimata, Nagakute-city, Aichi
TEL
0561623311
amanot@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Suzuki |
| Middle name | |
| Last name | Akihiro |
Organization
Aichi Medical University
Division name
cardiology
Zip code
4801195
Address
1-1 Yazakokarimata, Nagakute-city, Aichi
TEL
0561623311
Homepage URL
akis820@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Cardiology Aichi Medical University
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
Nagoya University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute-city, Aichi
Tel
0561623311
amu_ethics@aichi-med-u.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
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/31913164
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31913164
Number of participants that the trial has enrolled
51
Results
https://www.ncbi.nlm.nih.gov/pubmed/31913164
Results date posted
| 2020 | Year | 02 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://www.ncbi.nlm.nih.gov/pubmed/31913164
Participant flow
https://www.ncbi.nlm.nih.gov/pubmed/31913164
Adverse events
none
Outcome measures
https://www.ncbi.nlm.nih.gov/pubmed/31913164
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 24 | Day |
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
| 2017 | Year | 07 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032228
