UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of newly developed, optical-fiber based FFR device, comparing with conventional FFR devise using piezo electric sensors.
Title of the study (Brief title)	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	Hideki Ishii
Organization	Nagoya University Graduate School of Medicine
Division name	cardiology
Address	65 Tsurumai-cho, showa-ku, Nagoya,Japan
TEL	0527442147
Email	susumusuzuki@med.nagoya-u.ac.jp

Public contact
Name of contact person	Susumu Suzuki
Organization	Nagoya University Graduate School of Medicine
Division name	Cardiology
Address	65 Tsurumai-cho, showa-ku, Nagoya,Japan
TEL	0527442147
Homepage URL
Email	susumusuzuki@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024799