UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055566 |
|---|---|
| Receipt number | R000063468 |
| Scientific Title | CALcified coronary lesions treated by INtravascular lithotripsy with optical coherence TOmography assessment |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2025/02/15 21:59:36 |
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Basic information
Public title
CALcified coronary lesions treated by INtravascular lithotripsy with optical coherence TOmography assessment
Acronym
CALINTO Registry
Scientific Title
CALcified coronary lesions treated by INtravascular lithotripsy with optical coherence TOmography assessment
Scientific Title:Acronym
CALINTO Registry
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the present study is to investigate the association between intracoronary findings as assessed by OCT/OFDI and clinical outcomes in patients with calcified coronary lesions treated by IVL; and to explore the optimization conditions for IVL with OCT/OFDI assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target lesion failure defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically-indicated target vessel revascularization at 24 months
Key secondary outcomes
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 who fulfill all of the following criteria are eligible for the study.
(1) Patients diagnosed with chronic or acute coronary syndromes who have coronary lesions indicated for PCI
(2) Patients who have calcified coronary lesions treated by IVL with OCT/OFDI assessment
(3) Patients aged 18 years or older at the time of informed consent
(4) Patients with written consent
Key exclusion criteria
Patients who fulfill any of the following criteria are not eligible for the study.
(1) Patients unable to undergo OCT/OFDI assessment of the target lesion during PCI
(2) Patients deemed inappropriate by the investigator(s)
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Yonetsu |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo Ward, Tokyo
TEL
03-5803-5231
t-yonetsu.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyo |
| Middle name | |
| Last name | Sugiyama |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo Ward, Tokyo
TEL
03-5803-5231
Homepage URL
tsugi.cvm@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Taishi Yonetsu
Funding Source
Organization
None
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
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo Ward, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.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
| 2024 | Year | 09 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will be followed up at 7 days, 12 months, and 24 months. Patients will undergo follow up coronary angiography and OCT/OFDI assessment at 12 months after initial PCI if deemed necessary by the investigators.
Patients who experience cardiac events (i.e. acute coronary syndrome) clinically indicated for coronary angiography, OCT/OFDI assessment will be performed.
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063468
