Performance of the new generation BOBBY balloon guide catheter for endovascular treatment of acute ischemic stroke: results of the prospective, multicentric STRAIT study

BACKGROUND: Balloon guide catheters (BGCs) are used during mechanical thrombectomy to arrest or reverse blood flow in order to improve revascularization results. OBJECTIVE: STRAIT was an early post-market study of the new generation BOBBY BGC to evaluate performance and safety in the treatment of anterior circulation large vessel occlusion (LVO). METHODS: This prospective, core lab-controlled multicenter study was conducted across nine sites in Germany and Switzerland. Key inclusion criteria were LVO at the distal internal carotid article through proximal M2, symptom onset to treatment initiation within 8 hours, National Institute of Health Stroke Scale (NIHSS) ≥5, and Alberta Stroke Program Early CT Score (ASPECTS) ≥6. RESULTS: After having reached the primary endpoint in the planned interim analysis, enrollment was stopped early. Therefore, STRAIT enrolled 171 subjects from April 2022 to September 2023. Included patients were 49.7% female, median age was 73 years, and median NIHSS was 15. The primary endpoint of successful final reperfusion, as defined by Thrombolysis In Cerebral Infarction (TICI) 2b-3, was achieved in 94.7% of cases (n=161), and modified first pass effect (FPE) was 63.1%, with a median procedure time of 51 min. There were no device malfunction-related serious adverse events or adverse events. At final follow-up, 107/171 subjects (65.2%) had good neurological function (modified Rankin Scale ≤2) and an overall mortality of 8.5%. CONCLUSION: Mechanical thrombectomy using BOBBY BGC demonstrates high rates of FPE and overall success with a good safety profile, further supporting the additional benefit of the new generation BGCs in interventional stroke treatment. TRIAL REGISTRATION NUMBER: NCT05361187.