Introduction The use of a Balloon Guide catheter (BGC) in mechanical thrombectomy (MT) procedures might be associated with better technical and clinical results.

Aim of Study The next generation Bobby BGC (Microvention Inc.) has been evaluated in the prospective, multicenter, single-arm observational post-market STRAIT trial.

Methods Prospective data from 171 patients enrolled in the STRAIT study were analyzed. Key inclusion criteria included acute ischemic stroke (AIS) within the anterior cerebral circulation, occlusions ranging from M1 to proximal M2, treatment initiated within 8 hours of symptom onset, NIH Stroke Scale (NIHSS) ≥ 5, ASPECT Score ≥ 6. Angiographic and clinical characteristics, technical proficiency, and 90-day outcomes were evaluated and analyzed, controlled by an independent core lab and the clinical event committee.

Results The population of 171 patients (49,7% female) with a median age of 73 years and a median NIHSS of 15 presented in 58.2% with M1- and in 25,3% with M2-occlusions. The primary endpoint of final successful recanalization mTICI 2b/3 was reached in 94.7% of cases. Secondary outcome results included a modified First Pass Effect (mFPE) in 63.1% of cases, and a median procedure time of 40 minutes. 61,6% (N=164) showed independent functional outcome with modified Rankin Scale (mRS) of 0-2. ENTs were observed in 4.7%, verified by independent core lab assessment. No device malfunction-related adverse events were reported.

Conclusion As one of the new generation BGCs, the Bobby demonstrated a very high effectiveness and safety profile, further underlining the positive effect of Balloon Guidance support during mechanical thrombectomies.

Disclosure of Interest yes TBB: PI of the STRAIT study, STRAIT Study is industry sponsored by MicroVention.