UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025089
Receipt number R000028641
Scientific Title The Comparison of Diagnostic Performance of Fractional Flow Reserve between the use of 4 Fr and 6 Fr catheters in Intermediate Coronary Artery Stenosis
Date of disclosure of the study information 2016/11/30
Last modified on 2020/11/12 11:00:13

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Basic information

Public title

The Comparison of Diagnostic Performance of Fractional Flow Reserve between the use of 4 Fr and 6 Fr catheters in Intermediate Coronary Artery Stenosis

Acronym

COmparison of Fractional Flow Reserve Measurements through 4 FrEnch versus 6 FrEnch Diagnostic Catheter - COFFEE trial -

Scientific Title

The Comparison of Diagnostic Performance of Fractional Flow Reserve between the use of 4 Fr and 6 Fr catheters in Intermediate Coronary Artery Stenosis

Scientific Title:Acronym

COmparison of Fractional Flow Reserve Measurements through 4 FrEnch versus 6 FrEnch Diagnostic Catheter - COFFEE trial -

Region

Japan


Condition

Condition

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish the efficacy of FFR measurement using 4Fr diagnostic catheters

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation of FFR value measured by 4Fr and 6Fr catheters

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) Patients who are indicated for coronary angiography or coronary intervention.
2) Patients with more than 50% stenosis in main coronary artery
3) Patients with indicated FFR value (more than 0.70, less than 0.90), measured by 4Fr diagnostic catheter

Key exclusion criteria

1) Patients who are contraindicated to adenosine
2) Patients who have bronchial asthma
3) Patients who have a second degree of AV block or third degree of AV block.
4) Patients who have hemodialysis
5) Patients who have severe renal dysfunction (Crea; more than 2.0mg/dL)
6) Inadequate lesion for FFR measurement
7) Patients with unstable hemodynamic conditions
8) Patients with LVEF less than 30%

Target sample size

70


Research contact person

Name of lead principal investigator

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

Email

futoshi-yamanaka@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Moriyama

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

e2718nm@gmail.com


Sponsor or person

Institute

Shonankamakura General Hospital

Institute

Department

Personal name



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 11 Month 30 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

2016 Year 09 Month 12 Day

Date of IRB

2016 Year 09 Month 12 Day

Anticipated trial start date

2016 Year 10 Month 06 Day

Last follow-up date

2018 Year 07 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

no special instruction


Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2020 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028641


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name