UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000021545