UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial
Title of the study (Brief title)	A bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions
Region	Japan

Condition
Condition	Coronary artery disease with bifurcation lesions
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To collect cases of bioresorbable vascular scaffold (BVS) implantation using provisional stenting in the side branch of coronary bifurcation lesions and preliminary assess the safety and efficacy of BVS in comparison with the historical data of two-stent strategy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The late loss of the side branch in bifurcation at 8 and 20 months after PCI.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Everolimus-eluting BVS (Absorb, Abbott Vascular)
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) Patients or substitute decision-makers willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence (2) Patients eligible for percutaneous coronary intervention (3) Patients with coronary bifurcation stenosis (4) Patients with the necessity of stenting in the side branch after kissing balloon technique during provisional stenting (5) Visually estimated target lesion reference vessel diameter, 2.5-3.75mm and lesion length,<=24 mm in the side branch (6) Patients who can take double antiplatelet agents for 12 months
Key exclusion criteria	(1)Unable to be followed up by the implementing medical institution (2)Life expectancy <2 years (3)Allergic or contraindicative to the materials used for BVS (4)Scheduled for elective treatment requiring antiplatelet drug withdrawal (5)Possibility of pregnancy or lactation (6)Deemed as unsuitable by the investigator or sub-investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Yasushi Fuku
Organization	Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Division name	Department of Cardiology
Address	1-1-1, Miwa, Kurashiki, Okayama
TEL	086-422-0210
Email	fuku@kchnet.or.jp

Public contact
Name of contact person	Yasushi Fuku
Organization	Public interest incorporated foundation Ohara HealthCare Foundation
Division name	Department of Cardiology
Address	1-1-1, Miwa, Kurashiki, Okayama
TEL	086-422-0210
Homepage URL
Email	fuku@kchnet.or.jp

Sponsor
Institute	Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital Department of Cardiology
Institute
Department

Funding Source
Organization	Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital Department of Cardiology
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	2015 Year 03 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 05 Day
Anticipated trial start date	2015 Year 03 Month 09 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	2015 Year 03 Month 06 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018192