Status:
TERMINATED
BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Cerebrovascular Stroke
Eligibility:
All Genders
18-85 years
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 t...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT05361187
Start Date
April 8 2022
End Date
December 30 2023
Last Update
January 7 2025
Active Locations (9)
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1
Neuro-Kopf-Zentrum Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany
2
Martin Luther Universität Halle
Halle, Halle, Germany, 06120
3
Neurologische Klinik Abteilung für Neuroradiologie
Heidelberg, Germany
4
Klinikum Ingolstadt, Zentrum für Radiologie und Neuroradiologie
Ingolstadt, Germany