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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000010581 | Registry Identifier | UMIN Clinical Trial Registry |
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| Name | Class |
|---|---|
| Wakayama Medical University | OTHER |
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This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.
Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.
This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how OFDI or IVUS imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.
We will enroll the first 100 patients who have enrolled in the main-study of OPINION trial.(UMIN000010580). We will assess lesions by the other device in addition to the assigned device in the main study at the time of post-PCI.
We will then assess lesions by OFDI at a 8-month follo-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFDI-guided PCI & IVUS | Experimental |
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| IVUS-guided PCI & OFDI | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFDI-guided PCI & IVUS | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Minimum stent area by OFDI | The investigators will assess "Minimum stent area" by OFDI at post-PCI. | at just after the PCI |
| Frequency of malapposed struts | The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI. | at just after the PCI |
| Dissection | The investigators will assess "Dissection" by OFDI at post-PCI. | at just after the PCI |
| Minimum stent area by IVUS | The investigators will assess "Minimum stent area" by IVUS at post-PCI. | at just after the PCI |
| Frequency of uncovered struts | The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI. | 8 months after PCI |
| Minimum lumen area | The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI. | 8-month follow-up after PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takashi Akasaka, MD, PhD | Wakayama Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wakayama Medical University | Wakayama | Wakayama | 641-8510 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28917678 | Derived | Otake H, Kubo T, Takahashi H, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Kozuma K, Ioji T, Kaneda H, Akasaka T; OPINION Investigators. Optical Frequency Domain Imaging Versus Intravascular Ultrasound in Percutaneous Coronary Intervention (OPINION Trial): Results From the OPINION Imaging Study. JACC Cardiovasc Imaging. 2018 Jan;11(1):111-123. doi: 10.1016/j.jcmg.2017.06.021. Epub 2017 Oct 5. |
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| IVUS-guided PCI & OFDI | Device |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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