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

Acute Myocardial Infarction Clinical Trial

— TOBIAS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914055
• Other study ID #: Arezzo009
• Status: Recruiting
• Phase: Phase 4
• First received: July 12, 2013
• Last updated: October 21, 2013
• Start date: July 2013

Study information

• Verified date: October 2013
• Source: Ospedale San Donato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Myocardial Infarction

Intervention

Device:
• angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)
angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)
• 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)

Locations

Country	Name	City	State
Italy	Cardiovascular Department, Ospedale S.Donato	Arezzo	AR

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	within the primary PCI procedure	Yes
Secondary	major adverse cardiac events	rate of major adverse cardiac events at 6 months from the index procedure	at 6 months	Yes