UMIN-CTR Clinical Trial

Basic information
Public title	Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance
Acronym	PROVISION study
Scientific Title	Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance
Scientific Title:Acronym	PROVISION study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the revascularization rate based on angiography-derived fractional flow reserve compared to that based on angiography-derived fractional flow reserve.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Revascularization rate based on angiography-derived fractional flow reserve compared to that based on fractional flow reserve
Key secondary outcomes	Adverse events after one year(cardiac death, myocardial infarction, ischemia-driven revascularization, stroke, hospitalization due to heart failure) Costs of cardiac catheterization and revascularization Costs of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Treatment based on FFRangio asesssment
Interventions/Control_2	Treatment based on FFR asessment
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	120 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients for whom PCI is appropriate 2)Lesions whose visual diameter stenosis is greater than or equal to 30% and less than 90% 3)Lesions whose visual reference vessel diameter is greater than or equal to 2mm
Key exclusion criteria	1)Patients for whom PCI is not appropriate 2)Patients with within 72 hours of acute coronary syndrome 3)Patients with severe bronchial asthma or chronic obstructive pulmonary disease 4)Patients with heart failure categorized as NYHA class III or IV 5)Patients with allergy to contrast media
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Matsuo
Organization	Gifu Heart Center
Division name	Cardiology
Zip code	500-8384
Address	4-14-4 Yabutaminami, Gifu city, Gifu
TEL	058-277-2277
Email	matsuo@heart-center.or.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Tanigaki
Organization	Gifu Heart Center
Division name	Cardiology
Zip code	500-8384
Address	4-14-4 Yabutaminami, Gifu city, Gifu
TEL	058-277-2277
Homepage URL
Email	tanigaki@heart-center.or.jp

Sponsor
Institute	Gifu Heart Center
Institute
Department

Funding Source
Organization	Gifu Heart Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Gifu Heart Center Institutional Review Board
Address	4-14-4 Yabutaminami, Gifu city, Gifu
Tel	058-277-2277
Email	tomita@heart-center.or.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

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 16 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	400
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	No longer recruiting
Date of protocol fixation	2022 Year 07 Month 11 Day
Date of IRB	2022 Year 07 Month 11 Day
Anticipated trial start date	2022 Year 07 Month 11 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 10 Month 16 Day
Last modified on	2022 Year 10 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056068