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

Cerebrovascular Stroke Clinical Trial

— STRAIT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05361187
• Other study ID #: STRAIT
• Status: Terminated
• Start date: April 8, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 171
• Est. completion date: December 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Stroke
• Ischemic Stroke
• Stroke

Intervention

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).

Locations

Country	Name	City	State
Germany	Martin Luther Universität Halle	Halle(Saale)	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	Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität München	Munich	Bayern
Germany	Department of Neuroradiology, University Hospital of Paracelsus Medical Private University	Nürnberg
Switzerland	Devision Neuroradiology, Kantonsspital Aarau	Aarau
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne
Switzerland	Department of Neuroradiology, University hospital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Near complete reperfusion defined as mTICI=2c	mTICI evaluation per independent Core Lab members	90 days
Secondary	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
Secondary	90 days post-procedure modified Ranking Scale (mRS)	modified Ranking Scale (mRS) assessment and questionnaire at 90 days follow up visit.; The mRS has a scale from 0 till 6. 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead	90 days
Secondary	Mortality at 24 hours and 90 days	Serious adverse event evaluation validated by clinical event committee	24 hours and 90 days
Secondary	Safety evaluation device malfunction	Device related adverse event evaluation and follow up, validated by clinical event committee	90 days
Secondary	NIHSS at 24h post-procedure	NIHSS (National Institut Health Stroke Scale) evaluation by questionnaire to assess worsening of condition compared to baseline.; The NIHSS score covers 11 specific ability items. Each item can been scored between 0 and 4, with 0 indicating a normal function and higher scores indicating the lever of impairment. The total summ of all the ablity items is the total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.; 0 No stroke symptoms, 1-4, Minor stroke, 5-15 Moderate stroke,16-20 Moderate to severe stroke, 21-42 Severe stroke	24 hours
Secondary	Procedure related events	Procedure related events and outcome evaluation validated	24 hours
Secondary	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
Secondary	Occurrence of symptomatic intracranial hemorrhage (sICH) within 24 hours	procedure imaging assessment of imaging	24 hours