UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039397
Receipt number R000037570
Scientific Title The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.
Date of disclosure of the study information 2020/02/05
Last modified on 2021/08/09 21:53:19

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Basic information

Public title

The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.

Acronym

The correlation between sFFR and FFR

Scientific Title

The Accuracy of saline-induced FFR(sFFR) instead of fractional flow reserve(FFR) to evaluate the severity of coronary stenosis.

Scientific Title:Acronym

The correlation between sFFR and FFR

Region

Japan


Condition

Condition

coronary stenosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the accuracy and the security of saline-induced FFR in which saline is injected rapidly to the target coronary vessel.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The accuracy of saline-induced FFR

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Food Device,equipment

Interventions/Control_1

Adding sailne-induce FFR during coronary angiography with FFR & SFR

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

Primary registration
Patients with coronary angiography for coronary stenosis
Secondary registration
1 Patients with coronary artery disease who undergo coronary angiography and judged having stenosis with 50% or more by 2 interventionists (at least one of them including specialists in Japanese Association of Cardiovascular Intervention and Therapeutics)

2 no particular limitation of the lesion site (left anterior descending artery, left circumflex branch, right coronary artery), history of PCI, and lesion form (in stent restenosis, calcified lesion)
3 over 20 years old
4 patients obtained document consents by the patient's will with sufficient understanding after receiving sufficient explanation for the participation of this study

Key exclusion criteria

1) Patients with severe valvular disease
2) Patients with decompensated heart failure
3) Patients with extreme bradycardia (HR <40 or less)
4) Patients who can not use Adenosine necessary for FFR
5) Patients with co-morbidities such as acute liver injury and renal disorder that have serious effects on life
6) coronary total occlusion
7) Patients who are judged inappropriate for participation in this study by the responsible doctor


Target sample size

300


Research contact person

Name of lead principal investigator

1st name Arihiro
Middle name
Last name Kiyosue

Organization

The university of Tokyo Hospital

Division name

Cardiovascular Medicine

Zip code

113-8655

Address

Bunkyo-ku, Hongo, 7-3-1

TEL

03-3815-5411

Email

kiyosuea-int@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Kiriyama

Organization

The University of Tokyo Hospital

Division name

Cardiovascular Medicine

Zip code

113-8655

Address

Bunkyo-ku, Hongo, 7-3-1

TEL

03-3815-5411

Homepage URL


Email

kiriyaman0427@gmail.com


Sponsor or person

Institute

The university of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

The university of Tokyo 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

Graduate School of Medicine and Faculty of Medicine, The University of Tokyo,Intervention Research Ethics Committee

Address

Bunkyo-ku hongo 7-3-1, Tokyo, Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp


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

2020 Year 02 Month 05 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

2018 Year 12 Month 25 Day

Date of IRB

2019 Year 01 Month 29 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

2021 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 02 Month 05 Day

Last modified on

2021 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037570


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name