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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cerebrovascular Stroke
• Intervention / Treatment: Device: BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device

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.

• Study Type: Observational
• Enrollment (Anticipated): 270

Contacts and Locations

• Study Contact: Name: Hermien Atassi; Phone Number: +41799223640; Email: hermien.atassi@microvention.com
• Study Contact Backup: Name: Patricia Boyer; Email: patricia.boyer@microvention.com

Study Locations

• Germany
  • Heidelberg, Germany
    • Recruiting
    • Neurologische Klinik Abteilung für Neuroradiologie
    • Contact: Markus Moehlenbruch, MD
  • Ingolstadt, Germany
    • Not yet recruiting
    • Klinikum Ingolstadt, Zentrum für Radiologie und Neuroradiologie
    • Contact: Hendrik Janssen, MD
  • Kiel, Germany
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Contact: Fritz Wodarg, MD
  • Nürnberg, Germany
    • Not yet recruiting
    • Department of Neuroradiology, University Hospital of Paracelsus Medical Private University
    • Contact: Markus Holtmannspoetter, MD
  • Bayern
    • Munich, Bayern, Germany
      • Recruiting
      • Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität München
      • Contact: Tobias Boeckh-Behrens, Dr. med.
• Switzerland
  • Aarau, Switzerland
    • Not yet recruiting
    • Devision Neuroradiology, Kantonsspital Aarau
    • Contact: Luca Remonda, MD
  • Lausanne, Switzerland
    • Not yet recruiting
    • Centre Hospitalier Universitaire Vaudois (CHUV)
    • Contact: Guillaume Saliou, MD
  • Zürich, Switzerland
    • Not yet recruiting
    • Department of Neuroradiology, University hospital Zürich
    • Contact: Zsolt Kulcsár, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Principal Investigator: Tobias Boeckh-Behrens, MD, Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität; Study Director: Patricia Boyer, Microvention-Terumo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Anticipated): April 8, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Thrombectomy; Cerebrovascular Stroke; Balloon Guide Catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: STRAIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes