UMIN ID: UMIN000055566
Registered date:20/09/2024
CALcified coronary lesions treated by INtravascular lithotripsy with optical coherence TOmography assessment
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Coronary artery disease |
| Date of first enrollment | 2024/11/01 |
| Target sample size | 350 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Target lesion failure defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically-indicated target vessel revascularization at 24 months |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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) |
Related Information
| Primary Sponsor | Tokyo Medical and Dental University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomoyo Sugiyama |
| Address | 1-5-45, Yushima, Bunkyo Ward, Tokyo Japan 113-8519 |
| Telephone | 03-5803-5231 |
| tsugi.cvm@tmd.ac.jp | |
| Affiliation | Tokyo Medical and Dental University Hospital Department of Cardiovascular Medicine |
| scientific contact | |
| Name | Taishi Yonetsu |
| Address | 1-5-45, Yushima, Bunkyo Ward, Tokyo Japan |
| Telephone | 03-5803-5231 |
| t-yonetsu.cvm@tmd.ac.jp | |
| Affiliation | Tokyo Medical and Dental University Hospital Department of Cardiovascular Medicine |