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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047713
Receipt No. 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 2022/05/11

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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
Email 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
Email takey@yamaguchi-u.ac.jp

Sponsor
Institute Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department

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
Email 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 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 Enrolling by invitation
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
2022 Year 05 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054382

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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