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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018618
Receipt No. R000021545
Scientific Title Assessment of Safety and Efficacy of Rapid Exchange Fractional Flow Reserve Microcatheter in Patients with Intermediate Coronary Stenosis
Date of disclosure of the study information 2015/09/01
Last modified on 2020/03/18

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Basic information
Public title Assessment of Safety and Efficacy of Rapid Exchange Fractional Flow Reserve Microcatheter in Patients with Intermediate Coronary Stenosis
Acronym FFR by Rapid Exchange Microcatheter
Scientific Title Assessment of Safety and Efficacy of Rapid Exchange Fractional Flow Reserve Microcatheter in Patients with Intermediate Coronary Stenosis
Scientific Title:Acronym FFR by Rapid Exchange Microcatheter
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of fractional flow reserve measurement using rapid exchange microcatheter in patient with intermediate coronary stenosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate of fractional flow reserve measurement using rapid exchange microcatheter
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Decision making of therapeutic strategy for patients with coronary artery disease based on the fractional flow reserve result.
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 with coronary artery disease requiring coronary angiography or coronary intervention
2) Patients with intermediate coronary stenosis (30 -70% on visual assessment)
3) Age = or > 20 years old
4) Patients who can provide written informed consent documents
Key exclusion criteria 1) Chronic total occlusion
2) Acute myocardial infarction
3) Contraindication for adenosine triphosphate
4) Patients with severe reduced ejection fraction or severe valvular disease
5) Patients who can not provide written informed consents
6) Patients who were not suitable for enrollment
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Akasaka
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
Zip code 6418510
Address 811-1 Kimiidera Wakayama, Japan
TEL 073-447-2300
Email akasat@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Yasutsugu
Middle name
Last name Shiono
Organization Wakayama Medical University
Division name Department of Cardiovascular Medicine
Zip code 6418510
Address 811-1 Kimiidera Wakayama
TEL 073-447-2300
Homepage URL
Email doors@herb.ocn.ne.jp

Sponsor
Institute Wakayama Medical University
Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization ACIST Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Wakayama Medical University
Address 811-1 Kimiidera Wakayama
Tel 073-447-2300
Email wa-rinri@wakayama-med.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 和歌山県立医科大学(和歌山県)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 36
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
2015 Year 08 Month 06 Day
Date of IRB
2015 Year 08 Month 17 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2020 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021545

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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