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

NCT01914055 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-10-22

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DEVICE

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

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

DEVICE

OCT-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)

Sponsors & Collaborators

  • Ospedale San Donato

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01914055 on ClinicalTrials.gov