UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051840 |
|---|---|
| Receipt number | R000059031 |
| Scientific Title | Predictor for optimal vessel expansion in intravascular imaging findings after intravascular Lithotripsy |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2024/08/29 12:33:05 |
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Basic information
Public title
Predictor for optimal vessel expansion in intravascular imaging findings after intravascular Lithotripsy
Acronym
Predictor for optimal vessel expansion in intravascular imaging findings after intravascular Lithotripsy
Scientific Title
Predictor for optimal vessel expansion in intravascular imaging findings after intravascular Lithotripsy
Scientific Title:Acronym
Predictor for optimal vessel expansion in intravascular imaging findings after intravascular Lithotripsy
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to detect OCT findings to predict the vessel expansion after IVL in treatment of patients with coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The achievement rate of expansion rate greater than 80% or optimal minimum lumen area evaluated by OCT or IVUS at post procedure.
Key secondary outcomes
target vessel failure, target lesion restenosis, target vessel restenosis, non-fatal myocardial infarction, cardiovascular death, all-cause death
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients age is equal or greater than 18 years old.
Patients had the lesion that fulfill with the indication, calcium score, for IVL
Written informed consent was obtained
Key exclusion criteria
Allergy of contrast agent
Imaging device, OCT/IVUS, did not pass the lesion.
Adequate imaging was not obtained
Severe renal dysfunction (eGFR <30ml/min/1.73m2)
Judged by the principal investigator to be ineligible for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toshitaka |
| Middle name | |
| Last name | Okabe |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Cardiology
Zip code
224-8503
Address
35-1, Chigasaki-chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL
045-949-7000
alone_with_music@hotmail.com
Public contact
Name of contact person
| 1st name | Toshitaka |
| Middle name | |
| Last name | Okabe |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Cardiology
Zip code
224-8503
Address
35-1, Chigasaki-chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
alone_with_music@hotmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
self-sustaining
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
Showa university
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-u.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
| 2023 | Year | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059031
