Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study. (TOBIAS)
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility 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
Sites / Locations
- Cardiovascular Department, Ospedale S.DonatoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
angio-guided thrombus aspiration
OCT-guided thrombus aspiration
Arm Description
thrombus aspiration guided by angiography
thrombus aspiration guided by optical coherence tomography
Outcomes
Primary Outcome Measures
number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography
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
major adverse cardiac events
rate of major adverse cardiac events at 6 months from the index procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01914055
Brief Title
Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
Acronym
TOBIAS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Donato
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
angio-guided thrombus aspiration
Arm Type
Active Comparator
Arm Description
thrombus aspiration guided by angiography
Arm Title
OCT-guided thrombus aspiration
Arm Type
Experimental
Arm Description
thrombus aspiration guided by optical coherence tomography
Intervention Type
Device
Intervention Name(s)
angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
Intervention Description
angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)
Intervention Type
Device
Intervention Name(s)
OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
Intervention Description
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 Measure Information:
Title
number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography
Description
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)
Time Frame
within the primary PCI procedure
Secondary Outcome Measure Information:
Title
major adverse cardiac events
Description
rate of major adverse cardiac events at 6 months from the index procedure
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cardiovascular Department, Ospedale S.Donato
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese
Email
leonardobolognese@hotmail.com
First Name & Middle Initial & Last Name & Degree
Leonardo Bolognese, MD, FESC
First Name & Middle Initial & Last Name & Degree
Giovanni Falsini, MD
First Name & Middle Initial & Last Name & Degree
Paolo Angioli, MD
First Name & Middle Initial & Last Name & Degree
Kenneth Ducci, MD
First Name & Middle Initial & Last Name & Degree
Francesco Liistro, MD
First Name & Middle Initial & Last Name & Degree
Simone Grotti, MD
First Name & Middle Initial & Last Name & Degree
Italo Porto, MD
12. IPD Sharing Statement
Learn more about this trial
Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
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