A randomised controlled trial of DIRECT endovascular clot retrieval versus standard bridging thrombolysis with endovascular clot retrieval within 4.5 hours of stroke onset
Lead PI: Prof Peter Mitchell & Prof Bernard Yan
Status: Recruiting
No. of Patients Currently Recruited: 93 No. of Patients Required: 780
DIRECT-SAFE is a multicentre, prospective, randomised, open label, blinded endpoint (PROBE) non-inferiority phase 3 trial (2 arm with 1:1 randomisation to either Direct endovascular clot retrieval or to bridging intravenous thrombolysis with endovascular clot retrieval) in ischemic stroke patients within 4.5 hours of stroke onset. Randomised patients are stratified for site stoke onset. Randomised patients are stratified for site of baseline arterial occlusion and geographic region.
Trial URL:
ANZCTR No: ACTRN12615000618550
ClinicalTrials.gov: NCT03494920
