UMIN-CTR Clinical Trial

Basic information
Public title	Use of the Zenith; Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissection
Acronym	Use of the Zenith; Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissection
Scientific Title	Use of the Zenith; Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissection
Scientific Title:Acronym	Use of the Zenith; Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissection
Region	Japan North America

Condition
Condition	Acute, Complicated Type B Aortic Dissection
Classification by specialty	Vascular surgery Radiology Cardiovascular surgery Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To collect safety and effectiveness date from clinical use of the TXD-2
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary safety endpoint will be rate of freedom from major adverse events at 30 days. The primary effectiveness endpoint will be the survival rate at 30 days.
Key secondary outcomes	ability to deliver and deploy the device(s), clinical utility measures, major adverse events, retrograde progression of dissection, changes in true and false lumen sizes, presence of and sources for false lumen flow, extent of false lumen thrombosis, reinterventions, and device integrity

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 deploy
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	A patient is deemed suitable for inclusion in the study if the patient has an acute, complicated, Type B aortic dissection with at least one of the following characteristics : 1)Aortic rupture; or 2)Branch vessel obstruction/compromise resulting in malperfusion
Key exclusion criteria	General Exclusion Criteria 1)Age < 18 years; 2)Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years); 3)Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 4)Unwilling or unable to comply with the follow-up schedule; 5)Inability or refusal to give informed consent; or 6)Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) *Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.
Target sample size	67

Research contact person
Name of lead principal investigator	1st name Middle name Last name Cook Research Incorporated
Organization	Cook Research Incorporated
Division name	President
Zip code
Address	1 Geddes Way West Lafayette, IN 47906 US
TEL	+1-765-463-7537
Email	Jennifer.Kerr@CookMedical.com

Public contact
Name of contact person	1st name Middle name Last name Emiko Mori
Organization	Cook Incorporated
Division name	Clinical Affairs
Zip code
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 Research Incorporated
Institute
Department

Funding Source
Organization	Cook Research Incorporated
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪大学医学部附属病院、東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 22 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
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	2011 Year 11 Month 04 Day
Date of IRB	2012 Year 11 Month 20 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2019 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 03 Month 16 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 10 Month 15 Day
Last modified on	2020 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010688