UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of organ disfunction related with stentgraft placement
Title of the study (Brief title)	The evaluation of organ disfunction related with stentgraft placement
Region	Japan

Condition
Condition	aortic disease
Classification by specialty	Surgery in general Vascular surgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study about organ disfunction related with stent graft placement
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival, clinical findings, blood test, image study
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	10 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients underwent stentgraft placement
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	Yoshitsugu Nakamura
Organization	Chiba-Nishi General Hospital
Division name	The department of cardiovascular surgery
Address	107-1, Kanegasaku, Matsudo-shi, Chiba-ken
TEL	047-384-8111
Email	yohei4201@yahoo.com

Public contact
Name of contact person	Yohei Kawatani
Organization	Chiba-Nishi General Hospital
Division name	The department of cardiovascular surgery
Address	107-1, Kanegasaku, Matsudo-shi, Chiba-ken
TEL	047-384-8111
Homepage URL
Email	yohei4201@yahoo.com

Sponsor
Institute	Chiba-Nishi General Hospital
Institute
Department

Funding Source
Organization	None
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 04 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 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	Partially published
URL releasing results
Results	Correlations of perioperative coagulopathy, fluid infusion and blood transfusions with survival prognosis in endovascular aortic repair for ruptured abdominal aortic aneurysm. https://wjes.biomedcentral.com/articles/10.1186/s13017-016-0087-0; Development of Delirium in the Intensive Care Unit in Patients after Endovascular Aortic Repair: A Retrospective Evaluation of the Prevalence and Risk Factors. https://www.hindawi.com/journals/ccrp/2015/405817/ Contrast Medium Induced Nephropathy after Endovascular Stent Graft Placement: An Examination of Its Prevalence and Risk Factors. https://www.hindawi.com/journals/rrp/2016/5950986/ Acute pancreatitis caused by pancreatic ischemia after TEVAR combined with intentional celiac artery coverage and embolization of the branches of the celiac artery. Kawatani Y, Kurobe H, Nakamura Y, Suda Y, Okuma Y, Sato S, Hashimoto T, Hori T. J Surg Case Rep. 2017 Feb 23;2017(2):rjx029. doi: 10.1093/jscr/rjx029
Other related information	None

Management information
Registered date	2016 Year 04 Month 19 Day
Last modified on	2017 Year 11 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025334