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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

Tracking Information
First Submitted Date  ICMJE July 12, 2013
First Posted Date  ICMJE August 1, 2013
Last Update Posted Date October 22, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2013)
major adverse cardiac events [ Time Frame: at 6 months ]
rate of major adverse cardiac events at 6 months from the index procedure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: angio-guided thrombus aspiration
    thrombus aspiration guided by angiography
    Intervention: Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
  • Experimental: OCT-guided thrombus aspiration
    thrombus aspiration guided by optical coherence tomography
    Intervention: Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 30, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01914055
Other Study ID Numbers  ICMJE Arezzo009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leonardo Bolognese, MD, Ospedale San Donato
Study Sponsor  ICMJE Ospedale San Donato
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ospedale San Donato
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP