UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021189 |
|---|---|
| Receipt number | R000024432 |
| Scientific Title | Efficacy and safety of endovascular aortic aneurysm repair usign fenestrated stentgraft |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2017/01/30 09:52:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of endovascular aortic aneurysm repair usign fenestrated stentgraft
Acronym
Efficacy and safety of endovascular aortic aneurysm repair usign fenestrated stentgraft
Scientific Title
Efficacy and safety of endovascular aortic aneurysm repair usign fenestrated stentgraft
Scientific Title:Acronym
Efficacy and safety of endovascular aortic aneurysm repair usign fenestrated stentgraft
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm
thoracoabdominal aortic aneurysm
Classification by specialty
| Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of endovascular aortic aneurysm repair using fenestrated stentgraft for the cases which are unsuitable for commercially available stentgraft.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2 year mortality
Key secondary outcomes
aneurysm-related mortality
abdominal branch patency
migration of stentgraft
the rate of secondary intervention
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
| Medicine |
Interventions/Control_1
endovascular aortic aneurysm repair
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)Obtaining informed consent
2)at least 2 years observable
3)No allergy for stainless or polyester
4)high risk for open surgery
5)unsuitable anatomy for commercially available stentgraft
Key exclusion criteria
1)pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kichikawa Kimihiko |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
840, Shijyocho, Kashihara, Nara
TEL
0744-29-8900
kkichika@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwakoshi |
Organization
Nara Medical University
Division name
Radiology
Zip code
Address
840, Shijyocho, Kashihara, Nara
TEL
0744-29-8900
Homepage URL
shinichi18548342@gmail.com
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024432
