Interim safety/outcome analysis through 94 enrolled patients showed reduced mortality with the use of NeuroFlo (CoAxia) catheter for the treatment of ischaemic strokes. The mortality rate in the group treated with the double balloon catheter in the abdominal aorta was 6.4% vs. 14.9% in the control group.
The purpose of the SENTIS (Safety and efficacy of NeuroFlo technology in ischaemic stroke) trial is to assess the safety and efficacy of the device, intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.
SENTIS is a prospective randomised, single blind, multi-centre trial designed to demonstrate the safety and efficacy of the NeuroFlo treatment relative to medical management alone in improving neurologic outcome. Principal investigator is Dr Ashfaq Shuaib, University of Alberta, US. Edmonton One hundred patients enrolled at 45 sites have been enrolled. Baseline NIHSS scores range from five to 18 and time from symptoms onset averages six hours at baseline. Treatment involves placement of a double balloon catheter in the abdominal aorta, with sequential inflation of the balloons in the infra- and supra-renal positions, with 70% luminal occlusion for 45 minutes.
Progression on NIHSS stroke index was encountered in 12.5% of the patients in the treated group and 37% in the patients in the control group. No serious cardiac, renal or aortic adverse events have been noted to date. Interim safety and outcome analysis of the 94 patients supports continuation of the trial and hints for reduced mortality in the treated group. Enrollment will continue through 2009.