UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Title of the study (Brief title)	Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Region	Japan

Condition
Condition	Abdominal aortic aneurysm
Classification by specialty	Vascular surgery Radiology Cardiovascular surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the success rate of TAE for T2EL following EVAR and association between technical aspects and aneurysm diameter change.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Aneurysm diameter change following TAE
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The cases treated by EVAR using commercially available device and underwent aneurysm enlargement due to T2EL The cases who underwent TAE for T2EL from January 2007 to December 2017.
Key exclusion criteria	The cases who underwent surgical treatment for sac enlargement without TAE.
Target sample size	150

Research contact person
Name of lead principal investigator	Shinichi Iwakoshi
Organization	Nara Medical University
Division name	Radiology
Address	840 Shijo-cho, Kashihara, Nara 634-8521, Japan
TEL	0744-29-8900
Email	shinichi18548342@gmail.com

Public contact
Name of contact person	Shinichi Iwakoshi
Organization	Nara Medical University
Division name	Radiology
Address	840 Shijo-cho, Kashihara, Nara 634-8521, Japan
TEL	0744-29-8900
Homepage URL
Email	shinichi18548342@gmail.com

Sponsor
Institute	Department of Radiology, Nara Medical University
Institute
Department

Funding Source
Organization	Self Funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	St. Marianna University Hospital Nagoya City University Hospital Kanazawa University Hospital Gifu University Hospital Kitazato University Hospital Tsukuba University Hospital Iwate Medical University Hospital Tokai University Hospital Okinawa Chubu Hospital Tenri Hospital Tottori University Hospital Yamanasi University Hospital Aichi Medical University Hospital Kumamoto University Hospital Osaka University Hospital
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	2018 Year 05 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 05 Day
Anticipated trial start date	2018 Year 07 Month 01 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	age, sex, aneurysm diameter, device used for EVAR, emboloic material for TAE,

Management information
Registered date	2018 Year 05 Month 15 Day
Last modified on	2018 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037169