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

NCT05361187 | Terminated DMC

• 1 other identifier: STRAIT
• Study Type: observational
• Target: 171
• Locations: 2 countries
• Sites: 9

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

Conditions

Cerebrovascular Stroke

Keywords

Cerebrovascular Stroke; Thrombectomy; Balloon Guide Catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Technical success: successful placement of the BOBBY™ BGC at the skull base

  90 days

• Near complete reperfusion defined as mTICI≥2c

  90 days

• Patients with modified First Pass Effect observed (mFPE: mTICI≥2b after one pass)

  90 days

• 90 days post-procedure modified Ranking Scale (mRS)

  90 days

• Mortality at 24 hours and 90 days

  24 hours and 90 days

Study Arms (1)

single arm, observational post market study

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

Interventions

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

single arm, observational post market study

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (9)

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

Munich, Bavaria, Germany

Location

Martin Luther Universität Halle

Halle, Halle, 06120, Germany

Location

Neurologische Klinik Abteilung für Neuroradiologie

Heidelberg, Germany

Location

Klinikum Ingolstadt, Zentrum für Radiologie und Neuroradiologie

Ingolstadt, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Department of Neuroradiology, University Hospital of Paracelsus Medical Private University

Nuremberg, Germany

Location

Devision Neuroradiology, Kantonsspital Aarau

Aarau, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

Location

Department of Neuroradiology, University hospital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tobias Boeckh-Behrens, MD

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

  PRINCIPAL INVESTIGATOR

• Patricia Boyer

  Microvention-Terumo, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 4, 2022
• Study Start: April 8, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CH (3); DE (6)