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Recruitment status
Unique ID issued by UMIN UMIN000025089
Receipt No. 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 2016/11/30

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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
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 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
Date of protocol fixation
2016 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 06 Day
Last follow-up date
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
2016 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.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


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