Abstract
BackgroundWe describe the first-in-human experience using the Balloon Occlusion Stroke Sheath (BOSS(TM)) balloon-guide catheter to perform stroke thrombectomy in 50 consecutive patients enrolled in the Flow Arrest Safety and Technical success with balloon-guide catheters trial. This aspiration system includes a novel 9.4F balloon-guide catheter conduit for the insertion and guidance of catheters with a balloon providing temporary flow arrest.MethodsThe Flow Arrest Safety and Technical success with balloon-guide catheter trial is a single-arm, prospective, multi-center, non-randomized, observational registry evaluating the use of the market-released BOSS(TM) balloon-guide catheter in adult patients diagnosed with an acute ischemic stroke attributable to large vessel occlusion. The purpose of the current trial was to assess the safety and technical success associated with the use of the BOSS(TM) balloon-guide catheter.ResultsFifty patients met inclusion criteria with a mean baseline National Institutes of Health Stroke Scale (NIHSS) of 16. Treatment devices, including aspiration and stent retriever devices, were used in a total of 88 passes. The BOSS(TM) balloon-guide catheter was compatible with all stroke thrombectomy treatment devices used in 98% (49/50) of procedures. Balloon inflation and flow arrest were achieved in 100% (50/50) and 98% (49/50) of cases, respectively. Balloon deflation and retraction were observed in 100% (50/50) of cases. Successful reperfusion (modified thrombolysis in cerebral infarction score > 2b) was achieved in 100% of cases with single-pass reperfusion achieved in 62% (31/50) of cases.ConclusionsThe BOSS(TM) balloon-guide catheter is a safe and technically effective adjunctive device for mechanical thrombectomy of acute ischemic stroke due to large vessel occlusion.