Acute Myocardial InfarctionPhase 4TOBIASNCT01914055
Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
A Phase 4 study testing angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) and OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) in people with Acute Myocardial Infarction, run by Ospedale San Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) and OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST elevation myocardial infarction
- Ages Eligible for Study: >18 years old
- Genders Eligible for Study: Both (female sex with child-bearing potential excluded)
Who cannot join
- occluded (TIMI 0) or sub occluded (TIMI 1) proximal vessel of estimated diameter ≥3mm
- intended use of thrombus aspiration
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, 52100
Leonardo Bolognese, leonardobolognese@hotmail.com
Leonardo Bolognese, MD, FESC
About this study
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan), OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)Device
angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)
OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)Device
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 group | Role | What they receive |
|---|---|---|
| angio-guided thrombus aspiration | Active comparator | thrombus aspiration guided by angiography Receives: Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) |
| OCT-guided thrombus aspiration | Experimental | thrombus aspiration guided by optical coherence tomography Receives: Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within the primary PCI procedure
Secondary outcomes (1)
major adverse cardiac events
rate of major adverse cardiac events at 6 months from the index procedure
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Bolognese, MD, Ospedale San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914055
- Sponsor's protocol ID
- Arezzo009
- Acronym
- TOBIAS
- Status last verified
- Oct 2013
- First submitted
- 12 Jul 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
- ClinicalTrials.gov ID
- NCT01914055
- Acronym / sponsor ID
- TOBIAS / Arezzo009
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angio-guided thrombus aspiration | Active comparator | Device: angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)thrombus aspiration guided by angiography |
| OCT-guided thrombus aspiration | Experimental | Device: OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)thrombus aspiration guided by optical coherence tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ST elevation myocardial infarction
- Ages Eligible for Study: >18 years old
- Genders Eligible for Study: Both (female sex with child-bearing potential excluded)
Key exclusion criteria (2 listed)
- occluded (TIMI 0) or sub occluded (TIMI 1) proximal vessel of estimated diameter ≥3mm
- intended use of thrombus aspiration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan) | Device | angio-guided thrombus aspiration |
| 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) | Device | OCT-guided thrombus aspiration |
Primary outcome
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)
1 secondary outcome
major adverse cardiac events
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) and OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan) in people with Acute Myocardial Infarction, run by Ospedale San Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.