UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective randomized trial comparing paclitaxel releasing balloon with everolimus eluting stent for the small coronary vessels
Title of the study (Brief title)	ORB 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 noninferiority efficacy of drug-coating balloons(DCB) compared with everolimus eluting stents(EES) for coronary artery disease in small vessels
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	percentage diameter stenosis of the target vessel at follow up angiography
Key secondary outcomes	all cause death acute coronary syndrome revascularization

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	drug coating balloon follow up duration 12 months follow up angiogram will be performed after 8months from initial therapy
Interventions/Control_2	everolimous eluting stent follow up duration 12 months follow up angiogram will be performed after 8months from initial therapy
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with coronary artery disease less than 2.75mm in diameter
Key exclusion criteria	Acute coronary syndrome heart failure person requiring dialysis pregnant women in stent restenosis case severe calcified vessel contraindicated to antiplatelet therapy
Target sample size	322

Research contact person
Name of lead principal investigator	Hiroshi Tamura
Organization	The Juntendo University Nerima Hospital
Division name	Department of Cardiology
Address	3-1-10 Takanodai Nerima-ku, Tokyo
TEL	03-5923-3111
Email	tamura5155@gmail.com

Public contact
Name of contact person	Hiroshi Tamura
Organization	The Juntendo University Nerima Hospital
Division name	Department of Cardiology
Address	3-1-10 Takanodai Nerima-ku, Tokyo
TEL	03-5923-3111
Homepage URL
Email	tamura5155@gmail.com

Sponsor
Institute	The Juntendo University Nerima Hospital Department of Cardiology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	順天堂大学医学部附属練馬病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 04 Day
Anticipated trial start date	2018 Year 01 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 06 Month 30 Day

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

Management information
Registered date	2018 Year 08 Month 10 Day
Last modified on	2018 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037079