BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke

Study Overview
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Brief Summary
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Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). To prevent clot particles migrating in other parts of the brain circulation during the thrombectomy, balloon guiding catheters are inserted. The aim of the study is to evaluate the safety and performance of the balloon guide catheter BOBBY™ by collecting information from patients, treated with a mechanical thrombectomy and the balloon guide catheter (BOBBY™) after acute ischemic stroke

Detailed Description
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The main objective of the STRAIT study is to assess the performance of the mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter (BGC) as adjunctive device for endovascular treatment of patients suffering from an anterior circulation acute ischemic stroke. Interventional procedures and clinical follow-up will be performed per standard of care. Patient health-related and imaging data will be collected as of stroke onset time up to 90 days follow up.

Official Title
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STRAIT: Evaluation of Safety and Performance of the BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke

Conditions
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Cerebrovascular Stroke

Intervention / Treatment
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* Device: BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 and ≤ 85 years of age Informed consent by the patient or legal authorized representative for data collection is obtained Patient eligible for the mechanical thrombectomy treatment with adjunctive use of the BOBBY™ BGC Patient presenting with an anterior circulation large-vessel occlusion of distal internal carotic artery (ICA ) through proximal M2 confirmed by computed tomograph angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA). Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging Treatment initiated (groin puncture) within 8 hours of symptom onset. Patient with a pre-treatment National Institutes of Health Stroke Scale (NIHSS) score ≥5 Patient with no personal condition disabling the site to contact him/her at 90 days after procedure Exclusion Criteria: Patient has evidence of cerebral ischemia in the posterior circulation Patient presents severe unilateral or bilateral carotid artery stenosis requiring stent treatment during the procedure Pregnancy or breastfeeding Patient presents other serious medical illness (e.g., cancer) with estimated life expectancy of less than 3 months Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation Patient is already participating in an investigational drug or device trial (change routine care of the patient) Patient has evidence of intracerebral hemorrhage on initial imaging Patient has a significant mass effect with midline shift

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single arm, observational post market study<br>Patients with an acute ischemic stroke with treatment including the BOBBY™ BGC | Device: BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device<br>* The BOBBY™ BGC used during a mechanical thrombectomy procedure (stent retriever alone, contact aspiration alone or stent retriever and contact aspiration) and according to the instruction for use (IFU).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the proportion of patients with successful reperfusion defined as mTICI≥2b per Core Laboratory evaluation. | Successful reperfusion defined as mTICI≥2b by independent Core Laboratory evaluation. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success: successful placement of the BOBBY™ BGC at the skull base | Bobby catheter placement evaluated at predefined segments (cervical, petrous, cavernous, paraclinoid) of the internal carotic artery (ICA) per independent Core Laboratory evaluation | 90 days | 
| Near complete reperfusion defined as mTICI≥2c | mTICI evaluation per independent Core Lab members | 90 days | 
| Patients with modified First Pass Effect observed (mFPE: mTICI≥2b after one pass) | mTICI result after first pass evaluated by independent Core Lab members | 90 days | 
| Patients with functional outcome at 90 days post-procedure defined by mRS | modified Ranking Scale (mRS) assessment and questionnaire at 90 days follow up visit | 90 days | 
| Mortality at 24 hours and 90 days | Serious adverse event evaluation validated by clinical event committee | 24 hours and 90 days | 
| Safety evaluation device malfunction | Device related adverse event evaluation and follow up, validated by clinical event committee | 90 days | 
| Neurological deterioration events at 24h post procedure | NIHSS evaluation by questionnaire to assess worsening of condition compared to baseline | 24 hours | 
| Procedure related events | Procedure related events and outcome evaluation validated | 24 hours | 
| Occurence of new territory embolization | Assessment by independent Core Lab members of DSA or MRA at the end of the procedure and at 24 hours | 24 hours | 
| Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours | procedure imaging assessment of imaging | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular Stroke, Thrombectomy, Balloon Guide Catheter