Acute Ischemic Stroke
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENeuro-vascular access
Adjunctive device providing a conduit for retrieval device during thrombectomy
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Posterior circulation stroke * Tandem occlusions * Cervical carotid stenosis * Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | Hospital discharge or 7 days | Incidence of device-related adverse events |
| Performance Evaluation | Completion of procedure | Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment |
Countries
United States
Outcome results
None listed