CellAegis Devices Inc has completed patient enrolment in a large-scale trial involving its autoRIC device, the Canadian company announced on Thursday.
The multinational, randomised, controlled, single-blind, parallel assignment clinical trial, CONDI 2, aims to further assess the efficacy of remote ischemic conditioning (RIC) in reducing clinical events in patients presenting with ST-segment-elevation myocardial infarction (STEMI) and receiving point of care treatment by paramedics in an ambulance.
A total of 2,600 STEMI patients were enrolled in ambulances in Denmark, Serbia and Spain.
The study is designed to show the benefit of RIC versus standard of care treatment in reducing cardiac death and hospitalisation for heart failure at 12 months in STEMI patients.
CellAegis expects data from the CONDI 2 trial to augment existing positive evidence related to the therapeutic benefits of RIC in the treatment of cardiovascular disease and procedure related kidney damage.
Topline results of the CONDI 2 trial are anticipated in mid-2019.
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