UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study
Title of the study (Brief title)	Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study
Region	Japan North America Europe

Condition
Condition	fusiform or saccular aneurysms
Classification by specialty	Medicine in general Radiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To collect safety and effectiveness date from clinical use of the ZTLP
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Device success, Procedural time, Condit usage during the procedure, Clinical utility measures, Morbidity, including the composite rate of major adverse events, Endleak, change in aneurysm size, migration, device patency, device integrity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Stent graft custody with catheter
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Descending thoracic fusiform aneurysm with diameter >5.0 cm 2) Descending thoracic fusiform aneurysm with a history of growth >0.5 cm per year 3) Descending thoracic saccular aneurysm >10 mm in depth and >20 mm in diameter
Key exclusion criteria	<General Exclusion Criteria> 1) Less than 20 years of age 2) Life expectancy less than 2 years 3) Pregnant or breastfeeding or planning on becoming pregnant within 60 months 4) Unwilling to company with the follow-up schedule 5) Inability or refusal to give informed consent 6) Less than 30 days beyond primary endpoint for other investigative drug or device study *Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.
Target sample size	50

Research contact person
Name of lead principal investigator	Cook Incorporated
Organization	Cook Incorporated
Division name	Regulatory Affairs
Address	750 Daniels Way, Bloomington, IN 47404 US
TEL	+1-800-346-2235
Email	Ted.Heise@cookmedical.com

Public contact
Name of contact person	Yasuhito Shimizu
Organization	Cook Japan Incorporated
Division name	Clinical Affairs
Address	Nakano Central Park East, Nakano 4-10-1, Nakano, Tokyo, Japan
TEL	03-6853-9450
Homepage URL
Email	cookjapan-com@umin.net

Sponsor
Institute	Cook Japan Incorporated
Institute
Department

Funding Source
Organization	Cook Incorporated
Organization
Division
Category of Funding Organization	Profit organization
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	東京慈恵会医科大学附属病院（東京都）、森之宮病院（大阪府）、慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 08 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2017 Year 12 Month 01 Day
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

Management information
Registered date	2011 Year 05 Month 09 Day
Last modified on	2018 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006227