Clinical trial NCT05361187: BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
Official title: STRAIT: Evaluation of Safety and Performance of the BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebrovascular Stroke
Keywords: Cerebrovascular Stroke
Thrombectomy
Balloon Guide Catheter
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from an anterior circulation acute ischemic stroke eligible to mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter will be screened consecutively by the enrolling center. The patients will be selected in accordance with inclusion and exclusion criteria.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is the proportion of patients with successful reperfusion defined as mTICI≥2b per Core Laboratory evaluation.
timeFrame: 90 days
Secondary outcomes:
measure: Technical success: successful placement of the BOBBY™ BGC at the skull base
timeFrame: 90 days
measure: Near complete reperfusion defined as mTICI≥2c
timeFrame: 90 days
measure: Patients with modified First Pass Effect observed (mFPE: mTICI≥2b after one pass)
timeFrame: 90 days
measure: 90 days post-procedure modified Ranking Scale (mRS)
timeFrame: 90 days
measure: Mortality at 24 hours and 90 days
timeFrame: 24 hours and 90 days
measure: Safety evaluation device malfunction
timeFrame: 90 days
measure: NIHSS at 24h post-procedure
timeFrame: 24 hours
measure: Procedure related events
timeFrame: 24 hours
measure: Occurence of new territory embolization
timeFrame: 24 hours
measure: Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität München
state: Bayern
city: Halle(Saale)
country: Germany
facility: Martin Luther Universität Halle
state: Halle
city: Heidelberg
country: Germany
facility: Neurologische Klinik Abteilung für Neuroradiologie
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt, Zentrum für Radiologie und Neuroradiologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Nürnberg
country: Germany
facility: Department of Neuroradiology, University Hospital of Paracelsus Medical Private University
city: Aarau
country: Switzerland
facility: Devision Neuroradiology, Kantonsspital Aarau
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: Zürich
country: Switzerland
facility: Department of Neuroradiology, University hospital Zürich
Study officials:
affiliation: Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität
name: Tobias Boeckh-Behrens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Microvention-Terumo, Inc.
name: Patricia Boyer
role: STUDY_DIRECTOR
References: