UMIN-CTR Clinical Trial

Basic information
Public title	Prevention of Type II Endoleak With Embolization of IMA Before Endovascular Aneurysm Repair
Acronym	Prevention of Type II Endoleak
Scientific Title	Prevention of Type II Endoleak With Embolization of IMA Before Endovascular Aneurysm Repair
Scientific Title:Acronym	Prevention of Type II Endoleak
Region	Japan

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

Objectives
Narrative objectives1	Prevention of Type II Endoleak
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	occurrence of type2 endoleak
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	embolization of IMA
Interventions/Control_2	no treatment
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	Patient more than 3 mm of diameter IMA. Patient more than 2 mm of diameter lumbar artery and patient IMA. Patient of aortoiliac type aneurysm.
Key exclusion criteria	Patient detemined as a unsuitable Emergency operation
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kimikazu Middle name Last name Hamano
Organization	Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name	Division of first surgery
Zip code	755-8505
Address	Ube, 755-8505, Japan
TEL	0836-22-2261
Email	osamu.y@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Samura
Organization	Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name	Division of first surgery
Zip code	755-8505
Address	Ube, 755-8505, Japan
TEL	0836-22-2261
Homepage URL
Email	m.samura@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
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	Center For Clinical Research, Yamaguchi University Hospital
Address	Ube, 755-8505, Japan
Tel	0836-22-2428
Email	me223@yamaguchi-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	2016 Year 04 Month 30 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	106
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 04 Month 14 Day
Date of IRB	2014 Year 04 Month 14 Day
Anticipated trial start date	2014 Year 04 Month 14 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 30 Day
Last modified on	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019869