Flow Arrest Safety and Technical Success With Balloon Guide Catheters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-12

Study Completion Date

2021-10-27

Brief Summary

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The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.

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Detailed Description

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This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Neuro-vascular access

Adjunctive device providing a conduit for retrieval device during thrombectomy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms
* Adult patient willing to provide Informed Consent
* Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6