UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062465 |
|---|---|
| Receipt number | R000071468 |
| Scientific Title | Prospective Evaluation of ECV Values and Aneurysm Expansion Post-EVAR for Abdominal Aortic Aneurysm Using Photon-Counting CT |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/30 12:01:25 |
* 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
A Prospective Observational Study on the Association Between Extracellular Volume (ECV) Fraction and Aneurysm Sac Enlargement Using Photon-Counting CT in Patients After Endovascular Aneurysm Repair for Abdominal Aortic Aneurysm
Acronym
Follow-up Study After Stent Grafting for Aortic Aneurysm Using Photon-Counting CT
Scientific Title
Prospective Evaluation of ECV Values and Aneurysm Expansion Post-EVAR for Abdominal Aortic Aneurysm Using Photon-Counting CT
Scientific Title:Acronym
Prospective PCCT-AAA-ECV Study
Region
| Japan |
Condition
Condition
Abdominal Aortic Aneurysm
Classification by specialty
| Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the extracellular volume (ECV) fraction of the aneurysm wall can predict future aneurysm sac enlargement after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aneurysm sac enlargement at 6 months and 1 year postoperatively
Definition of aneurysm sac enlargement:
- An increase in maximum short-axis diameter of 5 mm or more, or
- An increase of 10% or more
Key secondary outcomes
Annual rate of aneurysm expansion (mm/year)
Incidence of Type I-V endoleaks
Fat attenuation of the aneurysm wall
Reintervention
Aneurysm-related mortality
All-cause mortality
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
- Adult patients aged 20 years or older
- Patients whose renal function meets the criteria for contrast-enhanced CT examination
- Patients scheduled for routine contrast-enhanced CT between 1 month and 12 months after EVAR
- Patients who can provide written informed consent to participate in this study
Key exclusion criteria
- Patients with active infection
- Patients with inflammatory or dissecting aortic aneurysms
- Patients with connective tissue disease
- Patients who underwent emergency EVAR
- Cases of isolated iliac artery aneurysm
- Cases where consent is withdrawn by the patient at enrollment or during the follow-up period
- Cases with missing clinical laboratory data required for evaluation (e.g., hematocrit value) or long-term aneurysm diameter follow-up data
- Cases where accurate measurement or analysis of aneurysm wall ECV is impossible due to excessive motion artifacts, metallic artifacts, or other factors on imaging
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | hiroshi |
| Middle name | |
| Last name | doi |
Organization
WAKAYAMA MEDICAL UNIVERSITY
Division name
Department of Radiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0605
hiroshidoi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | saeko |
| Middle name | |
| Last name | kimura |
Organization
WAKAYAMA MEDICAL UNIVERSITY
Division name
Department of Radiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0605
Homepage URL
onishis@wakayama-med.ac.jp
Sponsor or person
Institute
WAKAYAMA MEDICAL UNIVERSITY
Institute
Department
Personal name
doi hiroshi
Funding Source
Organization
WAKAYAMA MEDICAL UNIVERSITY
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Wakayama Medical University Hospital
Address
811-1 Kimiidera, Wakayama City
Tel
073-447-2300
rinsyo-zimu@wakayama-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
| 2026 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071468
