BOBBY™ Balloon Guide Catheter
STRAIT: Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
"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."
- Patients
171
- Countries
Germany & Switzerland
- Clinical Centers
10
- Design
Single arm prospective
- Scope
Patients 18-85 y.o. presenting with an acute ischemic stroke from LVO in the anterior cerebral circulation that can be treated within 8 hrs from AIS symptom onset, Aspect ≥ 6 and NIHSS ≥ 5. Those eligible to be treated with BOBBY device adjunctive to SR and/or aspiration (If 6Fr aspiration, a SOFIA™ PLUS will be used).
- Purpose
To evaluate the safety and performance of the mechanical thrombectomy with the use of a BOBBY™ balloon guide catheter (BGC) in patients suffering an acute ischemic stroke in the anterior circulation.
Endpoints
Proportion of patients with vascular recanalization defined as mTICI≥2b per Core Lab evaluation
Efficacy results
Successful recanalization (mTICI 2b-3): 94.7%
Near complete reperfusion (mTICI 2c-3): 75.9%
Modified first pass effect (mFPE): 63.1%
Safety results
At 24 hrs:
Embolization in new territory (ENT): 5.4%
sICH: 0%
Any hemorrhage: 32%
At 90 days:
Mortality: 8.2%
Good functional outcome (mRS 0-2 or equal to pre-stroke): 65.2%
Excellent functional outcome (mRS 0-1 or equal to pre-stroke): 53.7%
LINK TO STUDY PAGE Clinical Trials.gov ID NCT05361187
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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