UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062251 |
|---|---|
| Receipt number | R000071231 |
| Scientific Title | An observational study using optical coherence tomography to analyze the mechanisms of expansion in intravascular lithotripsy for calcified coronary artery lesions. |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/15 20:35:46 |
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Basic information
Public title
An observational study using optical coherence tomography to analyze the mechanisms of expansion in intravascular lithotripsy for calcified coronary artery lesions.
Acronym
IVL-CAN study
Scientific Title
An observational study using optical coherence tomography to analyze the mechanisms of expansion in intravascular lithotripsy for calcified coronary artery lesions.
Scientific Title:Acronym
IVL-CAN study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanism of vessel expansion following intravascular lithotripsy (IVL) in severely calcified coronary lesions, particularly those with calcified nodules
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vessel structural changes observed after IVL, including calcium fracture and coronary dissection
Key secondary outcomes
Final stent expansion rate
Minimum stent area
Residual in-stent diameter stenosis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 years or older.
2. Patients who underwent percutaneous coronary intervention (PCI) using IVL for calcified coronary lesions.
3. Patients in whom optical coherence tomography (OCT) was used as the intravascular imaging modality during PCI.
Key exclusion criteria
1. Patients with acute myocardial infarction.
2. Patients with in-stent restenosis lesions.
3. Patients with chronic total occlusion lesions.
4. Patients who underwent balloon dilation with a balloon above 2.0 mm in diameter or debulking devices (rotational atherectomy or orbital atherectomy) before IVL.
5. Patients in whom a coronary stent was not implanted.
6. Patients with OCT images of insufficient quality for analysis.
7. Patients who are deemed inappropriate for inclusion in the study by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Koga |
Organization
Juntendo University Nerima Hospital
Division name
Department of Cardiology
Zip code
177-8521
Address
3-1-10, Takanodai, Nerima-ku, Tokyo
TEL
03-5923-3111
kogase@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Koga |
Organization
Juntendo University Nerima Hospital
Division name
Department of Cardiology
Zip code
177-8521
Address
3-1-10, Takanodai, Nerima-ku, Tokyo
TEL
03-5923-3111
Homepage URL
kogase@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.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
| 2026 | Year | 07 | Month | 16 | 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
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study includes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) using IVL under OCT guidance for coronary calcification lesions at participating institutions between March 1, 2024, and the date the research was approved.
Management information
Registered date
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071231
