Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.

Study Overview
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Brief Summary
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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.

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
* Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST elevation myocardial infarction Ages Eligible for Study: >18 years old Genders Eligible for Study: Both (female sex with child-bearing potential excluded) Exclusion Criteria: occluded (TIMI 0) or sub occluded (TIMI 1) proximal vessel of estimated diameter ≥3mm intended use of thrombus aspiration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: angio-guided thrombus aspiration<br>thrombus aspiration guided by angiography | Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)<br>* angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)<br>|
| Experimental: OCT-guided thrombus aspiration<br>thrombus aspiration guided by optical coherence tomography | Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events | rate of major adverse cardiac events at 6 months from the index procedure | at 6 months |