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

NCT ID: NCT05361187

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 171 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2023-12-30

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.

Conditions

Cerebrovascular Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

single arm, observational post market study

Patients with an acute ischemic stroke with treatment including the BOBBY™ BGC

BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device

Intervention Type: DEVICE

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).

Interventions

BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Microvention-Terumo, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Boeckh-Behrens, MD

Role: PRINCIPAL_INVESTIGATOR

Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität

Patricia Boyer

Role: STUDY_DIRECTOR

Microvention-Terumo, Inc.

Locations

Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Martin Luther Universität Halle

Halle, Halle, Germany

Neurologische Klinik Abteilung für Neuroradiologie

Heidelberg, , Germany

Klinikum Ingolstadt, Zentrum für Radiologie und Neuroradiologie

Ingolstadt, , Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, , Germany

Department of Neuroradiology, University Hospital of Paracelsus Medical Private University

Nuremberg, , Germany

Devision Neuroradiology, Kantonsspital Aarau

Aarau, , Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Department of Neuroradiology, University hospital Zürich

Zurich, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

STRAIT

Identifier Type: -

Identifier Source: org_study_id