UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047713 |
|---|---|
| Receipt number | R000054382 |
| Scientific Title | The observational study for the long-term follow-up of the participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair" |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2025/05/14 11:55:49 |
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Basic information
Public title
The observational study for the long-term follow-up of the participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair"
Acronym
The Long-term Follow-up for Preventing Type II Endoleak with Embolization of IMA
Scientific Title
The observational study for the long-term follow-up of the participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair"
Scientific Title:Acronym
The Long-term Follow-up for Preventing Type II Endoleak with Embolization of IMA
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the long-term outcomes of endovascular aortic repair with IMA embolization for the prevention of Type II endoleak.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of Type II endoleak
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The alive participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair"
Key exclusion criteria
Not applicable
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Kimikazu |
| Middle name | |
| Last name | Hamano |
Organization
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name
Surgery I
Zip code
755-8505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2261
surg-1@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Takeuchi |
Organization
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name
Surgery I
Zip code
755-8505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2261
Homepage URL
takey@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
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
Center For Clinical Research, Yamaguchi University Hospital
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi, Japan
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
| 2022 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
106
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study. Participants of the prospective randomized controlled trial "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair" performed (UMIN ID: UMIN000022147) are eligible. The endpoints of this study are following, occurrence of Type II endoleak, changes in aneurysmal diameter, and overall survival.
Management information
Registered date
| 2022 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | 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=R000054382
