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

October 21, 2013 updated by: Leonardo Bolognese, MD, Ospedale San Donato
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Recruiting
        • Cardiovascular Department, Ospedale S.Donato
        • Principal Investigator:
          • Leonardo Bolognese, MD, FESC
        • Sub-Investigator:
          • Giovanni Falsini, MD
        • Sub-Investigator:
          • Paolo Angioli, MD
        • Sub-Investigator:
          • Kenneth Ducci, MD
        • Sub-Investigator:
          • Simone Grotti, MD
        • Contact:
        • Sub-Investigator:
          • Francesco Liistro, MD
        • Principal Investigator:
          • Italo Porto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within the primary PCI procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 21, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arezzo009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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