Interim report of the SENTIS trial: cerebral perfusion augmentation via partial aortic occlusion in acute ischemic stroke.

Aim: The aim of this paper was to present the interim results of the the Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial.

Methods: The SENTIS study is a phase III, multi-center randomized prospective study to evaluate cerebral perfusion augmentation with partial aortic occlusion in acute ischemic stroke. The trial was designed to compare conventional management of stroke patients with stroke patients treated by partial occlusion of the abdominal aorta by the NeuroFlo device. Follow up was at 24 hours and 90 days.

Results: Of the 100 patients enrolled, 53 were randomized to treatment and 47 to control. Six patients enrolled to treatment were found to have specific exclusion criteria and were excluded. Therefore, 97 validated patients, 47 treated patients and 47 control patients were included in the analysis. Adverse events were evenly distributed, among the two cohorts of patients with 16 patients or 34% in each group, including fatal and non-fatal adverse events. However, the mortality was significantly lower for the treated population (6.4%) versus the control population (14.9%), with more stroke progression (8.5%) and hemorrhagic transformation of the stroke area (4.3%) in the control population.

Conclusion: The SENTIS trial was designed to test the hypothesis that the NeuroFlo system is safe to be used in humans and able to produce cerebral perfusion augmentation, based on imaging and neurological assessment at 24 hours and at 90 days. The preliminary data yielded by the interim analysis showed that the population enrolled in the trial was rather homogeneous regarding age, baseline NIHSS scores, and other risk factors, suggesting that the treated and control cohorts were similar. The analysis also showed that the adverse events were rather comparable between the two groups, suggesting the treatment procedure to be safe enough for continuation of the trial. The NeuroFlo system so far proved to be safe enough for clinical use and seems to be promising in improving survival in the acute stroke population.