UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016726
Receipt No. R000018192
Scientific Title Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial
Date of disclosure of the study information 2015/03/08
Last modified on 2018/09/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial
Acronym A bioresorbable vascular scaffold
for the side branch in coronary bifurcation lesions
Scientific Title Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasushi Fuku
Organization Public interest incorporated foundation Ohara HealthCare Foundation
Kurashiki Central Hospital
Division name Department of Cardiology
Zip code
Address 1-1-1, Miwa, Kurashiki, Okayama
TEL 086-422-0210
Email fuku@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Fuku
Organization Public interest incorporated foundation Ohara HealthCare Foundation
Division name Department of Cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2014 Year 11 Month 05 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.