UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025446 |
|---|---|
| Receipt number | R000029285 |
| Scientific Title | Hemodynamic assessment of endoleak using three-dimensional phase contrast magnetic resonance imaging in patients who underwent endovascular aneurysm repair. |
| Date of disclosure of the study information | 2016/12/28 |
| Last modified on | 2024/08/19 15:32:16 |
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Basic information
Public title
Hemodynamic assessment of endoleak using three-dimensional phase contrast magnetic resonance imaging in patients who underwent endovascular aneurysm repair.
Acronym
Hemodynamic assessment of endoleak with 4D-flow MRA
Scientific Title
Hemodynamic assessment of endoleak using three-dimensional phase contrast magnetic resonance imaging in patients who underwent endovascular aneurysm repair.
Scientific Title:Acronym
Hemodynamic assessment of endoleak with 4D-flow MRA
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Surgery in general | Vascular surgery | Radiology |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Three-dimensional phase contrast MRI(4D-flow) enables the assessment of arterial hemodynamics, flow vector, flow volume. Endoleaks can be associated with postoperative aneurysmal growth. The aim of this study is to demonstrate the utility of the hemodynamic assessment of endoleak with 4D-flow in association with post-EVAR AAA enlargement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic parameters using MRI (flow volume, flow velocity, flow vector).
Endoleak vessel diameter. Identification of persistent endoleak. Prognosis of post-EVAR AAA
The occurrence of clinical events.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent endovascular aneurysm repair.
Key exclusion criteria
1) emergency surgery
2) Patients who underwent EVAR with non-nitinol-stentgraft
3) Inability to obtain informed consent
4) Claustrophobia
5) Contraindication of contrast enhanced MRI
6) Inappropriate patients due to other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Unno |
Organization
Hamamatsu University School of Medicine
Division name
Division of Vascular Surgery, Second Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
unno@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Unno |
Organization
Hamamatsu University School of Medicine
Division name
Division of Vascular Surgery, Second Department of Surgery
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
Homepage URL
unno@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science, and technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, JAPAN
Tel
053-435-2680
rinri@hama-med.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
| 2016 | Year | 12 | Month | 28 | 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
155
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
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: single-center cohort study
Objective: Patients who underwent endovascular abdominal aortic aneurysm repair between January 1, 2013 and December 31,2015.
Measurements: Hemodynamics of endoleaks, Maximum aneurysmal diameter, Endoleak vessel diameter.
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029285
