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

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ClinicalTrials.gov Identifier: NCT01914055
Recruitment Status : Unknown
Verified October 2013 by Leonardo Bolognese, MD, Ospedale San Donato.
Recruitment status was:  Recruiting
First Posted : August 1, 2013
Last Update Posted : October 22, 2013
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2013
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Active Comparator: angio-guided thrombus aspiration
thrombus aspiration guided by angiography
Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)

Experimental: OCT-guided thrombus aspiration
thrombus aspiration guided by optical coherence tomography
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)




Primary Outcome Measures :
  1. number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography [ Time Frame: 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 :
  1. major adverse cardiac events [ Time Frame: at 6 months ]
    rate of major adverse cardiac events at 6 months from the index procedure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914055


Locations
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Italy
Cardiovascular Department, Ospedale S.Donato Recruiting
Arezzo, AR, Italy, 52100
Contact: Leonardo Bolognese       leonardobolognese@hotmail.com   
Principal Investigator: Leonardo Bolognese, MD, FESC         
Sub-Investigator: Giovanni Falsini, MD         
Sub-Investigator: Paolo Angioli, MD         
Sub-Investigator: Kenneth Ducci, MD         
Sub-Investigator: Francesco Liistro, MD         
Sub-Investigator: Simone Grotti, MD         
Principal Investigator: Italo Porto, MD         
Sponsors and Collaborators
Ospedale San Donato
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Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01914055    
Other Study ID Numbers: Arezzo009
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: October 22, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases