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The aim of this study is to assess clinical safety and efficacy of percutaneous coronary intervention (PCI) using a newer generation drug-eluting stent (DES) in the context of optical frequency domain imaging (OFDI) guidance or intravascular ultrasound (IVUS) guidance.
Intracoronary imaging techniques provide clinically useful information in the setting of PCI, such as lesion severity, tissue characterization, vessel sizing, and stent optimization. Current evidences suggest potential advantage of intracoronary imaging guidance in reducing the risk of major adverse cardiac events after stent implantation over conventional PCI under angiographic guidance alone. IVUS has been clinically used in two decades and it is known as one of the most dominant intracoronary imaging technique. OFDI is a new light-based intracoronary imaging technology which provides higher image resolution and higher-speed pullback compared to those of IVUS. Given the different properties between ultrasound-based IVUS and light-based OFDI, treatment and clinical impact of these two imaging techniques would be different.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFDI-guided PCI | Experimental |
| |
| IVUS-guided PCI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFDI | Device | PCI under OFDI guidance |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimum lumen area assessed by OFDI | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular mortality | 8 months | |
| Target vessel myocardial infarction | 8 months | |
| Target lesion revascularization |
| Measure | Description | Time Frame |
|---|---|---|
| Integrated Backscatter IVUS (IB-IVUS) | Plaque components including lipid pool, fibrosis, dense fibrosis or calcification | 0 month (pre-procedure) |
| Detectable external elastic lamina (EEL) arc assessed by OFDI |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University | Toyoake | 470-1192 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33106049 | Derived | Muramatsu T, Ozaki Y, Nanasato M, Ishikawa M, Nagasaka R, Ohota M, Hashimoto Y, Yoshiki Y, Takatsu H, Ito K, Kamiya H, Yoshida Y, Murohara T, Izawa H; MISTIC-1 Investigators. Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation: A Randomized MISTIC-1 Non-Inferiority Trial. Circ Cardiovasc Interv. 2020 Nov;13(11):e009314. doi: 10.1161/CIRCINTERVENTIONS.120.009314. Epub 2020 Oct 27. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| IVUS | Device | PCI under IVUS guidance |
|
|
| 8 months |
| Apposition of stent struts assessed by OFDI | 8 months |
| Tissue coverage of stent struts assessed by OFDI | 8 months |
| Quantitative Coronary Angiography (QCA) | 8 months |
| 0 month (pre-procedure) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |