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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01914055

Acronym

TOBIAS

Enrollment

Registered

2013-08-01

Start date

2013-07-31

Completion date

Unknown

Last updated

2013-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

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.

Interventions

DEVICEangio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)

angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)

DEVICEOCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
major adverse cardiac events	at 6 months	rate of major adverse cardiac events at 6 months from the index procedure

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026