Randomized Trial of Standard vs ClearWay-infused Abciximab and Thrombectomy for Myocardial Infarction
Status:
Unknown status
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Subjects with ST-elevation myocardial infarction will be randomized, to one of the following:
abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A),
thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy
followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that
abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration
(groups C or T+C) will result in a significant reduction of intra-stent thrombus formations
when compared to intravenous or intracoronary abciximab with or without thrombectomy (groups
A or T+A). The primary endpoint will be the number of cross sections with thrombus area >10%
immediately after stent implantation as assessed with OCT. Additional angiographic, ECG, and
clinical endpoints will be collected and adjudicated. This trial is currently being
registered at ClinicalTrials.gov.
Phase:
Phase 4
Details
Lead Sponsor:
CLI Foundation
Treatments:
Abciximab Antibodies, Monoclonal Immunoglobulin Fab Fragments