STRAIT Study:
Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
BOBBY™ Balloon Guide Catheter
STRAIT Study demonstrates that "Mechanical thrombectomy using BOBBY BGC demonstrates high rates of FPE and overall success with a good safety profile, supporting the additional benefit of the new generation BGCs in interventional stroke treatment."
- 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:
Explore other studies
STABILISE Study: Stroke: an evaluation of thrombectomy in the ageing brain version 1
SOFIA™ Aspiration Catheter & ERIC™ Stent Retriever
Request more information
The information you provide through this form is necessary to respond to your request and may be shared with the relevant Terumo Neuro group entity or entities responsible for handling it. For more information on how we process your personal data and on your rights, please refer to our privacy policy.