Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
NCT ID: NCT01914055
Last Updated: 2013-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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angio-guided thrombus aspiration
thrombus aspiration guided by angiography
angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)
OCT-guided thrombus aspiration
thrombus aspiration guided by optical coherence tomography
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)
Interventions
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angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)
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)
Eligibility Criteria
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Inclusion Criteria
* Ages Eligible for Study: \>18 years old
* Genders Eligible for Study: Both (female sex with child-bearing potential excluded)
Exclusion Criteria
* intended use of thrombus aspiration
18 Years
ALL
No
Sponsors
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Ospedale San Donato
OTHER
Responsible Party
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Leonardo Bolognese, MD
Director
Locations
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Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
Countries
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Facility Contacts
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Leonardo Bolognese
Role: primary
Other Identifiers
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Arezzo009
Identifier Type: -
Identifier Source: org_study_id