UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of usefulness of arterial stent placement for arterial pseudoaneurism
Title of the study (Brief title)	The analysis of usefulness of arterial stent placement for arterial pseudoaneurism
Region	Japan

Condition
Condition	intra-abdominal arterial pseudoaneurysm
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We analyze the usefulness of arterial stent placement for hemorrhage of intra-abdominal arterial pseudoaneurysm.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative complications, re-bleeding rates
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	approve the informed concent
Key exclusion criteria	no approve the informed concent
Target sample size	20

Research contact person
Name of lead principal investigator	Koji Asai
Organization	Toho University Ohashi Medical Center
Division name	Surgery
Address	2-17-6 Ohashi, Meguro, Tokyo
TEL	0334681251
Email	k-asai@mvg.biglobe.ne.jp

Public contact
Name of contact person	Koji Asai
Organization	Toho University Ohashi Medical Center
Division name	Surgery
Address	2-17-6 Ohashi, Meguro, Tokyo
TEL	0334681251
Homepage URL
Email	k-asai@mvg.biglobe.ne.jp

Sponsor
Institute	Toho University Ohashi Medical Center Surgery
Institute
Department

Funding Source
Organization	Toho University Ohashi Medical Center Surgery
Organization
Division
Category of Funding Organization	Other
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 10 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 02 Month 14 Day
Anticipated trial start date	2013 Year 04 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	no disclosure

Management information
Registered date	2016 Year 10 Month 19 Day
Last modified on	2016 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027397