UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE
Title of the study (Brief title)	HeartFlow ADVANCE Registry
Region	Japan North America Europe

Condition
Condition	Coronary Artery Diseases
Classification by specialty	Cardiology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes, and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (CAD), in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint of the ADVANCE Registry is the reclassification rate between the coronary management plan based on the review of the cCTA compared to the management plan based on FFRCT when obtained, as assessed by an independent review committee.
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	18 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Provide written informed consent 2. Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.
Key exclusion criteria	1. cCTA showing no CAD 2. Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation 3. Any active, serious, life-threatening disease with a life expectancy of less than 1 year 4. Inability to comply with follow-up requirements
Target sample size	7500

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

Public contact
Name of contact person	Reiko Masui
Organization	HeartFlow Japan
Division name	Clinical Affairs
Address	Nishihimbashi 1-18-6, 13F, Minato, Tokyo
TEL	03-3539-3730
Homepage URL
Email	rmasui@heartflow.com

Sponsor
Institute	Wakayama Medical University Hospital
Institute
Department

Funding Source
Organization	HeartFlow Inc
Organization
Division
Category of Funding Organization	Profit organization
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 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 25 Day
Anticipated trial start date	2015 Year 07 Month 07 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	The enrollment requires screening and informed consent. For the enrolled subjects, 4 follow up will be made, at 90 days, 180 days, 1 year and 3 year. The follow up can be made either phone or office visit.

Management information
Registered date	2018 Year 04 Month 10 Day
Last modified on	2018 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036662