UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	How does POst-PCI FFR value using pressure catheter relate to lesion prognosis or patient prognosis COmpaRed to aNatomical evaluation?
Title of the study (Brief title)	POPCORN study
Region	Japan

Condition
Condition	stable angina, acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to prospectively evaluate the relationship between fractional flow reserve immediately after percutaneous coronary intervention (PCI) and lesion prognosis or patient prognosis and to determine the cut-off value of post-PCI FFR predicting 12-month clinical events.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Fractional flow reserve immediately after percutaneous coronary intervention
Key secondary outcomes	Clinical events at 12 months (all cause death, cardiovascular death, non-fatal myocardial infarction, clinically-driven target vessel revascularization, stent thrombosis and stroke)

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Fractional flow reserve immediately after percutaneous coronary intervention
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Age 20 years or over, 2.stable angina or acute coronary syndrome with significant residual stenosis in the non-culplit artery after primary PCI, 3.ability to provide written informed consent
Key exclusion criteria	1. Left main coronary artery disease, 2.chronic total occlusion, 3. severe valvular heart disease, 4. unstable hemodynamics, 5.contraindications to antiplatelet therapy or anticoagulant therapy, 6. severe liver disease, lung disease, and malignant disease
Target sample size	200

Research contact person
Name of lead principal investigator	Takashi Akasaka
Organization	Wakayama Medical University
Division name	Department of Cardiovascular Medicine
Address	811-1, Kimiidera, Wakayama
TEL	073-447-2300
Email	cvm4@wakayama-med.ac.jp

Public contact
Name of contact person	Hironori Kitabata
Organization	Wakayama Medical University
Division name	Department of Cardiovascular Medicine
Address	811-1, Kimiidera, Wakayama
TEL	073-447-2300
Homepage URL
Email	cvm4@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2018 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035588