UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028268
Receipt No. 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 2018/07/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last name of lead principal investigator
1st name
Middle name
Last name Tetsuya Amano
Organization Aichi Medical University
Division name cardiology
Zip code
Address 1-1 Yazakokarimata, Nagakute-city, Aichi
TEL 0561623311
Email amanot@aichi-med-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akihiro Suzuki
Organization Aichi Medical University
Division name cardiology
Zip code
Address 1-1 Yazakokarimata, Nagakute-city, Aichi
TEL 0561623311
Homepage URL
Email akis820@aichi-med-u.ac.jp

Sponsor
Institute Department of Cardiology Aichi Medical University
Institute
Department

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
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
2017 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 07 Month 18 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032228

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.