UMIN-CTR Clinical Trial

Basic information
Public title	FORTUNA(Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients undergoing Transcatheter Aortic Valve Replacement)
Acronym	FORTUNA
Scientific Title	FORTUNA(Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients undergoing Transcatheter Aortic Valve Replacement)
Scientific Title:Acronym	FORTUNA
Region	Japan

Condition
Condition	severe aortic stenosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is still to be elucidated whether FFRct calculated from the preoperative CCTA data using computational flow dynamics is useful in patients with severe AS who plan to undergo TAVR as a predictor for myocardial ischemia and intraoperative complications. The objective of this study is to evaluate the relationship between pre-TAVR FFRct and post-TAVR invasive FFR to better understand the impact that non-administration of nitrates has on computed FFR values. In addition, this study also aims to evaluate the relationship between pre- and post-TAVR resting physiology (iFR) and post-TAVR invasive FFR in association with pre- and post-TAVR FFRct to better understand the impact of aortic valve stenosis on the resting coronary physiology. If the utility of FFRct can be established in patients with severe AS who plan to undergo TAVR based on the results of this research study, the necessity of the intervention in treatment of CAD prior to TAVR and the perioperative risk of TAVR can be evaluated, leading to the marked clinical significance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	A cut-off value for FFRct that can estimate FFR of <0.80 in patients with severe AS
Key secondary outcomes	(1)A cut-off value for pre-TAVR iFR that can estimate FFR of <0.80 in patients with severe AS (2)Regression and correlation coefficient of FFRct before TAVR and after TAVR (3)Regression and correlation coefficient of iFR before TAVR and after TAVR (4)Stenosis degree in coronary angiography before TAVR predicting FFR: <0.80 in severe AS patients

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The intervention tested in this study is to measure FFR using a guide wire that is capable of sensing pressure following TAVR. After the pressure gradient across the aortic valve is relieved by TAVR, it is considered that FFR can evaluate myocardial ischemia in a safe and accurate manner and can be used as the standard in contrast to pre and post-TAVR FFRct. Another intervention tested in this study is to measure iFR before and after TAVR to assess its potential to accurately estimate myocardial ischemia.
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	Patients who meet all the following criteria will be included in the study: 1)Among patients who have undergone CCTA prior to TAVR, those with moderate stenotic lesions (30 to <70%) or severe stenotic lesions on CT who are candidates for PCI following TAVR 2)Patients aged 20 years or older at the time of diagnosis
Key exclusion criteria	Patients who meet any one of the following criteria will be excluded from this study: 1)Patients who were implanted with metal stents in the left main trunk, 2)Patients with stenosis of >30% in the left main trunk who were implanted with at least one metal stent in the vessel(s) of the left coronary circulation, 3)Patients who were implanted with metal stents in at least 2 vessels of the coronary circulation, 4)Patients who requested withdrawal of consent for participation in this research study after providing their consent, 5)Patients who underwent coronary artery bypass surgery, 6)Patients with coronary artery chronic total occlusion, 7)Patients who developed acute myocardial infarction in the past 2 months, 8)Patients whose CCTA was determined to be unreadable during its evaluation at the study site because of the presence of artifacts which were severe enough to cause problems with the angiogram, 9)Patients who were judged by the principal investigator to be unsuitable for the study for other reasons
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiromasa Otake
Organization	Graduate School of Medicine, Kobe University
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL	078-382-5846
Email	hotake@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryo Takeshige
Organization	Graduate School of Medicine, Kobe University
Division name	Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL	078-382-5846
Homepage URL
Email	takeshige.kobe@gmail.com

Sponsor
Institute	Division of Cardiovascular Medicine, Department of Internal Medicine, Graduate School of Medicine, Kobe University
Institute
Department

Funding Source
Organization	none
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	2018 Year 09 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	Open public recruiting
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 25 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 10 Day
Last modified on	2020 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038024