search
Back to results

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
Ospedale San Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 12, 2013
Last Updated
October 21, 2013
Sponsor
Ospedale San Donato
search

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.

We'll reach out to this number within 24 hrs