Trials / Unknown
UnknownNCT01914055
Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Ospedale San Donato · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2015-07-01
- First posted
- 2013-08-01
- Last updated
- 2013-10-22
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01914055. Inclusion in this directory is not an endorsement.