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demonstrate that FD-OCT guidance is feasible and possibly results in reduction of frequency-domain Optical Coherence Tomography-defined residual thrombus burden after thrombus-aspiration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| angio-guided thrombus aspiration | Active Comparator | thrombus aspiration guided by angiography |
|
| OCT-guided thrombus aspiration | Experimental | thrombus aspiration guided by optical coherence tomography |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) | Device | angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan) |
| Measure | Description | Time Frame |
|---|---|---|
| number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography | Whether FD-OCT guidance of manual thrombus aspiration (TA) is superior to conventional angio-guided TA in reducing residual thrombus burden after stenting (defined as the number of cross-sections with thrombus area more than 10% at post-stenting FD-OCT) | within the primary PCI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiac events | rate of major adverse cardiac events at 6 months from the index procedure | at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Department, Ospedale S.Donato | Recruiting | Arezzo | AR | 52100 | Italy |
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| OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) | Device | FD-OCT-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan); OCT images will be acquired at the site of culprit coronary artery with a commercially available system (Lunawave System; Fastview catheter/Terumo, Tokio, Japan OR C7 System; LightLab Imaging Inc; C7 Dragonfly catheter/St Jude Medical, Westford, MA) |
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