UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness and safety study of branched stent-graft for aortic arch disease
Acronym	Effectiveness and safety study of branched stent-graft for aortic arch disease
Scientific Title	Effectiveness and safety study of branched stent-graft for aortic arch disease
Scientific Title:Acronym	Effectiveness and safety study of branched stent-graft for aortic arch disease
Region	Japan

Condition
Condition	aortic arch disease
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the effectiveness and safety of branched stent graft for aortic arch disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	freedom from aortic rupture/enlargement at 6 month postoperatively
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Endovascular arotic repair
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	aortic arch pathologies in open repair high risk patient which are excluded from endovascular treatment using approved straight stent graft.
Key exclusion criteria	Patients who do not satisfy the anatomical inclusion criteria for branched device
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Sawa Middle name Last name Yoshiki
Organization	Osaka University Graduate School of Medicine
Division name	Department of cardiovascular surgery
Zip code	565-0871
Address	Yamadaoka 2-2, Suita
TEL	06-6879-3154
Email	sawa@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Shimamura Middle name Last name Kazuo
Organization	Osaka University Graduate School of Medicine
Division name	Department of cardiovascular surgery
Zip code	565-0871
Address	Yamadaoka 2-2, Suita
TEL	06-6879-3154
Homepage URL
Email	shimamura@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Osaka University
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	Osaka University Graduate School
Address	Yamadaoka 2-2, Suita
Tel	06-6210-8090
Email	mirai@hp-mctr.med.osaka-u.ac.jp

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 11 Month 06 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	Terminated
Date of protocol fixation	2015 Year 11 Month 01 Day
Date of IRB	2017 Year 09 Month 06 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2018 Year 08 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 06 Day
Last modified on	2020 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022722