UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058324 |
|---|---|
| Receipt number | R000066678 |
| Scientific Title | Study on the Assessment of Coronary Stent Lumen Using Photon-Counting Detector CT |
| Date of disclosure of the study information | 2025/08/31 |
| Last modified on | 2025/06/30 20:02:39 |
* 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
Study on the Assessment of Coronary Stent Lumen Using Photon-Counting Detector CT
Acronym
Study on the Assessment of Coronary Stent Lumen Using Photon-Counting Detector CT
Scientific Title
Study on the Assessment of Coronary Stent Lumen Using Photon-Counting Detector CT
Scientific Title:Acronym
Study on the Assessment of Coronary Stent Lumen Using Photon-Counting Detector CT
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the accuracy of coronary stent lumen assessment between photon-counting detector CT (PCD-CT) and energy-integrating detector CT (EID-CT)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
lumen area
Key secondary outcomes
stent diameter stent area lumen diameter
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Patients who underwent coronary stent lumen assessment using either PCD-CT or EID-CT.
- Patients who underwent OCT evaluation of coronary stent lumen within one month before or after CT imaging.
Key exclusion criteria
- Patients with poor CT image quality due to motion artifacts or other factors.
- Patients whose OCT images are of insufficient quality for evaluation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
0783825111
taka02222003@gmail.com
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Takata |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
0783825111
Homepage URL
forestwwood13@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe 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
the Ethics Committee of Kobe University Hospital
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
0783825111
forestwwood13@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
兵庫県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 31 | 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
| 2025 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 30 | 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
none
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066678
