UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033357
Receipt number R000038024
Scientific Title FORTUNA(Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients undergoing Transcatheter Aortic Valve Replacement)
Date of disclosure of the study information 2018/09/01
Last modified on 2020/01/14 12:39:08

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038024


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name