UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009113 |
|---|---|
| Receipt number | R000010688 |
| Scientific Title | Use of the Zenith; Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissection |
| Date of disclosure of the study information | 2012/10/22 |
| Last modified on | 2020/03/26 13:27:44 |
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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
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
cookjapan-com@umin.net
Sponsor or person
Institute
Cook Research Incorporated
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010688
