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

San Donato Group (GSD)

Status and phase: Unknown; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan); Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)

Study type: Interventional

Funder types: Other

Identifiers

NCT01914055

Arezzo009

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

angio-guided thrombus aspiration

Active Comparator group

Description:

thrombus aspiration guided by angiography

Treatment:

Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)

OCT-guided thrombus aspiration

Experimental group

Description:

thrombus aspiration guided by optical coherence tomography

Treatment:

Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)