Unique ID issued by UMIN | UMIN000051624 |
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Receipt number | R000058903 |
Scientific Title | De Novo Calcified Lesions Treated with Optical Coherence Tomography guidance and Intravascular Lithotripsy Registry |
Date of disclosure of the study information | 2023/07/17 |
Last modified on | 2023/07/16 10:55:44 |
De Novo Calcified Lesions Treated with Optical Coherence Tomography guidance and Intravascular Lithotripsy Registry
DIRO IVL
De Novo Calcified Lesions Treated with Optical Coherence Tomography guidance and Intravascular Lithotripsy Registry
DIRO IVL
Japan |
Coronary artery disease
Cardiology |
Others
NO
The aim of this study is to evaluate efficacy and safety of intravascular lithotripsy with optical coherence tomography guidance for calcified lesions.
Safety,Efficacy
Stent expansion assessed by opticalcoherence tomography
Optical coherence tomography findings including tissue modification
Complications during the procedure such as perforation, slow or no flow, coronary dissection, periprocedural myocardial infarction
Procedure time, contrast volume
Clinical events at 8 months after the procedure
Optical coherence tomograpy findings at 8 months after the procedure
Observational
18 | years-old | < |
Not applicable |
Male and Female
Patients with stable coronary artery disease eligible for perdutaneous coronary intervention
Calcified lesions with OCT-based calcium score of 3 or higher
Left main coronary artery ostium or right coronary artery ostium lesions
Patients with a possibility of being pregnant
Patients with life expectancy of less than 12 months
50
1st name | Masami |
Middle name | |
Last name | Nishino |
Osaka Rosai Hospital
Division of Cardiology
591-8025
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
072-252-3561
mnishino@osakah.johas.go.jp
1st name | Naotaka |
Middle name | |
Last name | Okamoto |
Osaka Rosai Hospital
Division of Cardiology
591-8025
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
072-252-3561
okamo10nao@osakah.johas.go.jp
Osaka Rosai Hospital
None
Other
Osaka Rosai Hospital
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
072-252-3561
soumukatyou@osakah.johas.go.jp
NO
2023 | Year | 07 | Month | 17 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 05 | Month | 06 | Day |
2023 | Year | 06 | Month | 02 | Day |
2023 | Year | 07 | Month | 12 | Day |
2026 | Year | 06 | Month | 30 | Day |
Patient data and procedural data including optical coherence tomography findings are collected at the procedure and 8 months after the procedure.
2023 | Year | 07 | Month | 16 | Day |
2023 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058903
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