UMIN-CTR Clinical Trial

Basic information
Public title	The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Acronym	The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Scientific Title	The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Scientific Title:Acronym	The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Region	Japan

Condition
Condition	Aortic valve stenosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Fractional flow reserve (FFR) is a standard technique to assess the functional severity of coronary artery stenosis in the catheterization laboratory, whereas the instantaneous wave-free ratio (iFR) is being introduced as a new non-pharmacologic-stress index of coronary stenosis severity. The iFR could have great advantages in patients with severe aortic valve stenosis (AS), to evaluate physiologically intermediate coronary artery stenosis, because iFR measurement does not require pharmacologic stress test. However, its performance has not been explored yet. The aim of this research is to establish the impact of iFR in intermediate coronary artery stenosis in patients with severe AS.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Factorial analysis between ischemic score and iFR / FFR
Key secondary outcomes	Factorial analysis between iFR and FFR

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	a. Patients consented with this clinical research. b. Coronary angiography demonstrated more than 50% diameter stenosis by visual estimation.
Key exclusion criteria	a. contra-indication to ATP b. lesion with chronic total occlusion c. acute myocardial infarction within 3 months d. inadequate lesion for FFR/iFR e. vessels which connected to bypass graft f. severe renal dysfunction g. hemodialysis patients
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeru Saito
Organization	Shonankamakura General Hospital
Division name	Department of Cardiology and Catheterization Laboratory
Zip code
Address	1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL	0467-46-1717
Email	transradial@kamakuraheart.org

Public contact
Name of contact person	1st name Middle name Last name Futoshi Yamanaka
Organization	Shonankamakura General Hospital
Division name	Department of Cardiology and Catheterization Laboratory
Zip code
Address	1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL	0467-46-1717
Homepage URL
Email	futoshi-yamanaka@nifty.com

Sponsor
Institute	Shonankamakura General Hospital
Institute
Department

Funding Source
Organization	Shonankamakura General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 10 Month 19 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	Completed
Date of protocol fixation	2015 Year 04 Month 06 Day
Date of IRB	2015 Year 04 Month 06 Day
Anticipated trial start date	2015 Year 04 Month 07 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	no comment to declare

Management information
Registered date	2016 Year 10 Month 19 Day
Last modified on	2020 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028143