UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034174 |
|---|---|
| Receipt number | R000038955 |
| Scientific Title | Investigation for optimal protocol using diluted ionic contrast medium during angiography |
| Date of disclosure of the study information | 2018/09/26 |
| Last modified on | 2026/03/24 23:25:20 |
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Basic information
Public title
Investigation for optimal protocol using diluted ionic contrast medium during angiography
Acronym
Diluted ionic contrast medium during angiography
Scientific Title
Investigation for optimal protocol using diluted ionic contrast medium during angiography
Scientific Title:Acronym
Diluted ionic contrast medium during angiography
Region
| Japan |
Condition
Condition
arterial diseases
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal protocol using diluted ionic contrast medium during angiography
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of diluted ionic contrast medium during endovascular treatment for arterial diseases
Key secondary outcomes
Effect of diluted contrast medium on kidney function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
During the endovascular treatment for arterial diseases, angiogram using diluted ionic contrast medium will be performed
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
Any patient over 20 years old, who will be receiving endovascular treatment using ionic contrast medium, and has given written consent to participate to the study
Key exclusion criteria
1) Patients allergic to ionic contrast medium
2) End stage renal insufficiency (eGFR < 15 ml/min) contraindicated to any ionic contrast medium
3) Patients determined to be unfit to participate the study by the attending physician. (for example, dementia)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Fujimura |
Organization
Saiseikai Central Hospital
Division name
Cardiovascular Surgery
Zip code
108-0073
Address
1-4-17, Mita, Minato-ku, Tokyo
TEL
03-3451-8211
naokif0212@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Fujimura |
Organization
Saiseikai Central Hospital
Division name
Cardiovascular Surgery
Zip code
1080073
Address
1-4-17 Mita, Minato, Tokyo, Japan
TEL
03-3451-8211
Homepage URL
naokif0212@gmail.com
Sponsor or person
Institute
Saisekai Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Saisekai Central Hospital
Address
1-4-17 Mita, Minatoku, Tokyo, Japan
Tel
03-3451-8211
tikenjimu@saichu.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
| 2018 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.annalsofvascularsurgery.com/article/S0890-5096(25)00478-9/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.annalsofvascularsurgery.com/article/S0890-5096(25)00478-9/fulltext
Number of participants that the trial has enrolled
28
Results
In this study, LC-DSA during EVAR reduced contrast use by ~75% without affecting clinical outcomes, but worsened image quality and increased radiation exposure; no CIN occurred. A total of 28 patients (17 LC-DSA, 11 control) were included; baseline characteristics were generally similar except for larger aneurysms in the LC-DSA group. The primary endpoint was technical success; secondary endpoints included contrast volume, radiation dose, fluoroscopy time, DSA number, image quality, and renal function.
Results date posted
| 2026 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 28 patients who underwent EVAR were included in this study (17 in the LC-DSA group and 11 in the control group). The mean age was approximately 77 years, and the majority of patients were male. The aneurysm diameter was significantly larger in the LC-DSA group, while no significant differences were observed in other baseline characteristics, including hypertension, diabetes mellitus, coronary artery disease, cerebrovascular disease, smoking history, and use of antiplatelet or anticoagulant therapy. The prevalence of chronic kidney disease (eGFR <60 mL/min) was comparable between the groups. Although the proportion of patients with an ASA score >3 tended to be higher in the LC-DSA group, this difference was not statistically significant. Overall, the baseline characteristics were generally well balanced between the two groups.
Participant flow
IC was obtained using paper document
Adverse events
none
Outcome measures
The primary endpoint of this study was technical success, defined as successful stent graft deployment without intraoperative complications and the absence of type 1 and type 3 endoleaks on the initial postoperative CT angiography. Secondary endpoints included contrast medium volume, radiation dose, fluoroscopy time, number of DSA acquisitions, objective image quality assessment (contrast value and contrast-to-noise ratio), subjective image evaluation using a 4-point grading scale, and postoperative renal function changes, including the occurrence of contrast-induced nephropathy defined as a 25% decline in eGFR within 30 days after EVAR.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038955
