UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan study of Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect.
Title of the study (Brief title)	Japan study of Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect.
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether iFR/FFR guided treatment strategy makes the postulated treatment strategy by CAG guide change and to analyze the cost-effectiveness of its dual diagnosis. To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Primary outcome of medical economy The cost-effectiveness of iFR/FFR hybrid strategy 2. Primary outcome of physiological assessment Alteration in treatment protocol Change in SYNTAX score
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age>=20 years old. 2. Patient who can understand informed consent of the clinical study and signed the consent. 3. Patient who is adaptable to CAG and/or coronary revascularization 4. Patient who has evaluated stenotic lesion (stenosis>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it.
Key exclusion criteria	1. Patient with known contraindications to ATP and/or papaverine hydrochloride 2. Target vessel diameter<=2.0mm 3. Lesion with CTO (registration allowed if other branch has stenosis more than 50% in visual judgment) 4. Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block. 5. AMI patient 6. Patient who is disqualified for FFR and coronary revascularization by the investigator. 7. Lesion is disqualified for PCI by the investigator. 8. Patient who has critical valvular disease of heart. (moderate or severe AS/AR/MS/MR) 9. Patient with a prior CABG on target vessel. 10. Patient with severe renal dysfunction. (serum creatinine>=2.0mg/dl) 11. Patient on hemodialysis. 12. Body weight>=200kg 13. Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate<50/min, SBP<90mmHg) 14. Patient who expects to live less than 2 years at the registration 15. Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy. 16. Patient who is poor compliance with drug treatment. 17. Patient who is allergic to contrast agent. 18. LVEF>=30% 19. Patient who has the history of PCI with DES in recent 3 months before registration. 20. Patient who has the history of PCI with BMS or POBA in recent 1 year before registration. 21. Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI. 22. Patients with inadequacy to join this clinical study. 23. Patient who has been enrolled any other clinical study.
Target sample size	500

Research contact person
Name of lead principal investigator	Masato Nakamura
Organization	Toho University Ohashi Medical Center
Division name	Division of Cardiovascular Medicine
Address	2-17-6, Ohashi Meguro-ku, Tokyo 153-8515
TEL	+81-3-3468-1251
Email	masato@oha.toho-u.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	J-DEFINE support center
Division name	Soiken Inc.
Address	NFB Ogawa-cho Bldg 4F, 1-3-1, Kanda Ogawa-cho, Chiyoda-ku, Tokyo 101-0052
TEL	03-3295-1376
Homepage URL
Email	info@j-define.org

Sponsor
Institute	NPO Associations for Establishment of Evidence in Interventions
Institute
Department

Funding Source
Organization	NPO Associations for Establishment of Evidence in Interventions
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	2013 Year 10 Month 22 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 10 Month 17 Day
Anticipated trial start date	2013 Year 10 Month 28 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	nonrandomized, open-label, prospective, and multi-center observational study

Management information
Registered date	2013 Year 10 Month 22 Day
Last modified on	2016 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014143