UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047437 |
|---|---|
| Receipt number | R000054092 |
| Scientific Title | Utility of a new intracoronary optical coherence tomography imaging with a fast pullback speed |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2023/01/23 16:04:19 |
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Basic information
Public title
Utility of a new intracoronary optical coherence tomography imaging with a fast pullback speed
Acronym
A new intracoronary fast-pullback OCT imaging
Scientific Title
Utility of a new intracoronary optical coherence tomography imaging with a fast pullback speed
Scientific Title:Acronym
A new intracoronary fast-pullback OCT imaging
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the utility of a new fast-pullback optical coherence tomography (OCT) imaging (Gentuity) with respect to qualitative and quantitative OCT analysis, required contrast volume for image acquisition, and lesion crossability to the OCT catheters in comparison to the conventional OCT catheter /system (Abbott).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contrast volume required for OCT image acquisition
Key secondary outcomes
The longitudinal length of analyzable OCT images, the crossability of the OCT catheters, qualitative and quantitative OCT analysis, adverse events during the OCT image aquisition
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
1. Patients scheduled for OCT imaging
2. Age20 >=years old
3. Obtained informed consent
Key exclusion criteria
1. Impaired renal function
2. Ectatic coronary arteries
3. Severe tortuosity or calcification
4. Massive thrombosis
5. No adequate coronary flow for OCT image acquisition
6. Poor OCT images
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishi |
Organization
Kawasaki Medical School
Division name
Department of Cardiology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
0864621111
tnishi@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishi |
Organization
Kawasaki Medical School
Division name
Department of Cardiology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
0864621111
Homepage URL
tnish@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Unrestricted research grant at Kawasaki Medical School
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama, Japan
Tel
0864641076
kmsrec@med.kawasaki-m.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 | 04 | Month | 30 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 01 | Month | 23 | Day |
Other
Other related information
This study investigates whether the new OCT catheter/system can evaluate coronary artery lesions with lower contrast volume and comparable quantitative and qualitative accuracy compared with the conventional OCT by performing these 2 OCT evaluations in the same coronary arteries in the same patients.
Management information
Registered date
| 2022 | Year | 04 | Month | 08 | Day |
Last modified on
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054092
