UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005576 |
|---|---|
| Receipt number | R000006227 |
| Scientific Title | Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study |
| Date of disclosure of the study information | 2011/05/11 |
| Last modified on | 2018/05/14 10:00:16 |
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Basic information
Public title
Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study
Acronym
Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study
Scientific Title
Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Cook Incorporated |
Organization
Cook Incorporated
Division name
Regulatory Affairs
Zip code
Address
750 Daniels Way, Bloomington, IN 47404 US
TEL
+1-800-346-2235
Ted.Heise@cookmedical.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhito Shimizu |
Organization
Cook Japan 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 Japan Incorporated
Institute
Department
Personal name
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)
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
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 |
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
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006227
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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