UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of endovascular aortic aneurysm repair usign iliac branch device
Title of the study (Brief title)	Efficacy and safety of endovascular aortic aneurysm repair usign iliac branch device
Region	Japan

Condition
Condition	abdominal aortic aneurysm iliac artery aneurysm
Classification by specialty	Vascular surgery Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of endovascular aortic aneurysm repair using iliac branch device for preservation of hypogastric artery blood flow.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2 year mortality
Key secondary outcomes	aneurysm-related mortality hypogastric artery patency migration of stentgraft the rate of secondary intervention

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	Medicine
Interventions/Control_1	endovascular aortic aneurysm 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	1)Obtaining informed consent 2)at least 2 years observable 3)No allergy for stainless or polyester 4)high risk for open surgery 5)suitable anatomy for iliac branc device
Key exclusion criteria	1)pregnancy
Target sample size	10

Research contact person
Name of lead principal investigator	Kimihiko Kichikawa
Organization	Nara Medical University
Division name	Radiology
Address	840, Shijyocho, Kashihara, Nara
TEL	0744-29-8900
Email	kkichika@naramed-u.ac.jp

Public contact
Name of contact person	Shinichi Iwakoshi
Organization	Nara Medical University
Division name	Radiology
Address	840, Shijyocho, Kashihara, Nara
TEL	0744-29-8900
Homepage URL
Email	shinichi18548342@gmail.com

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
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	2016 Year 02 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2008 Year 01 Month 23 Day
Anticipated trial start date	2008 Year 01 Month 23 Day
Last follow-up date
Date of closure to data entry	2016 Year 12 Month 31 Day
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	2016 Year 02 Month 27 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024491