UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of PICC in treatment of acute aortic dissection Stanford type B
Title of the study (Brief title)	The efficacy of PICC in treatment of acute aortic dissection Stanford type B
Region	Japan

Condition
Condition	Patients with acute aortic dissectionwho admitted to Chiba-Nishi General Hospital
Classification by specialty	Surgery in general Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	TEVAR is being reported as novel teatment option for acute aortic dissection Stanford type B. But there are reports which are saying that TEVAR is related to several complications. On the other hand, conventional conservative teatment also has complications. We observe dermatitis and phlebitis in the treatment. This study is aimed to evaluate the complication.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phlebitis during the treatment period
Key secondary outcomes	The requirement of TEVAR for acute aortic dissection Stanford type B.

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	30 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	All of the patients who were admitted to Chiba-NIshi General Hospital.
Key exclusion criteria	None
Target sample size	50

Research contact person
Name of lead principal investigator	Takaki Hori
Organization	Chiba-Nishi General Hospital
Division name	The department of cardiovascular surgery
Address	Chiba-Nishi General Hospital, 107-1 Kanegasaku, Matsudo-Shi, Chiba-Ken 2702251, Japan
TEL	+81473848111
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	Chiba-Nishi General Hospital, 107-1 Kanegasaku, Matsudo-Shi, Chiba-Ken 2702251, Japan
TEL	+81473848111
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	2018 Year 01 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 30 Day
Anticipated trial start date	2014 Year 08 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	None

Management information
Registered date	2018 Year 01 Month 10 Day
Last modified on	2018 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035121