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

Phase 4

• Conditions: Acute Myocardial Infarction
• Interventions: Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan); Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)

• Registration Number: NCT01914055
• Lead Sponsor: Ospedale San Donato

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-21
• Last Update Posted: 2013-10-22
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
angio-guided thrombus aspiration	angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)	thrombus aspiration guided by angiography
OCT-guided thrombus aspiration	OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)	thrombus aspiration guided by optical coherence tomography

Primary Outcome Measures

Name	Time	Method
number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography	within the primary PCI procedure	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)

Secondary Outcome Measures

Name	Time	Method
major adverse cardiac events	at 6 months	rate of major adverse cardiac events at 6 months from the index procedure

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy