Unique ID issued by UMIN | UMIN000053266 |
---|---|
Receipt number | R000060789 |
Scientific Title | Prospective Investigation of Calcium Score in OCT-guided Revascularization to Identify Lesions with Low Risk for Stent Underexpansion |
Date of disclosure of the study information | 2024/01/05 |
Last modified on | 2024/02/19 08:24:25 |
Prospective Investigation of Calcium Score in OCT-guided Revascularization
to Identify Lesions with Low Risk for Stent Underexpansion
The CORAL Study
Prospective Investigation of Calcium Score in OCT-guided Revascularization
to Identify Lesions with Low Risk for Stent Underexpansion
The CORAL Study
Japan |
Ischemic Heart Disease
Cardiology |
Others
NO
To prospectively validate the ability of optical coherence tomography (OCT)-Ca score to identify calcified lesions with low risk for stent underexpansion after percutaneous coronary intervention (PCI)
Safety,Efficacy
Strategy success (successful stent placement with final percent diameter stenosis [%DS] <20% and Thrombolysis In Myocardial Infarction [TIMI] flow grade III without crossover to rotational atherectomy/orbital atherectomy/intravascular lithotripsy [RA/OA/IVL])
Observational
18 | years-old | <= |
Not applicable |
Male and Female
- Calcified lesions deemed low risk for stent underexpansion by OCT Ca score with planned balloon first strategy with NC/scoring/cutting balloon
- Stable coronary artery disease
- Patients older than 18 years old
- Informed consent obtained from the patient or his/her legal representative
- Acute coronary syndrome
- In-stent restenosis
- Chronic total occlusion
- PCI without stent
- No OCT pullbacks performed
- Unanalyzable OCT due to incomplete flush or artifact
130
1st name | Yuki |
Middle name | |
Last name | Katagiri |
Sapporo Higashi Tokushukai Hospital
Department of Cardiology
0650033
14 Chome-3-1 Kita 33 Johigashi, Higashi Ward, Sapporo, Hokkaido
0117221110
ykatagiri.ggl@gmail.com
1st name | Yuki |
Middle name | |
Last name | Katagiri |
Sapporo Higashi Tokushukai Hospital
Department of Cardiology
0650033
14 Chome-3-1 Kita 33 Johigashi, Higashi Ward, Sapporo, Hokkaido
0117221110
ykatagiri.ggl@gmail.com
Sapporo Higashi Tokushukai Hospital
None
Self funding
The Tokushukai Group Ethics Committee
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
+81-3-3263-4801
irb@mirai-iryo.com
NO
2024 | Year | 01 | Month | 05 | Day |
Unpublished
Enrolling by invitation
2023 | Year | 03 | Month | 24 | Day |
2023 | Year | 05 | Month | 10 | Day |
2023 | Year | 05 | Month | 23 | Day |
2025 | Year | 07 | Month | 31 | Day |
None
2024 | Year | 01 | Month | 04 | Day |
2024 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060789
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