Flow Arrest Safety and Technical Success With Balloon Guide Catheters (FAST-BGC)

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Medtronic

Status

Completed

Conditions

Acute Ischemic Stroke

Treatments

Device: Neuro-vascular access

Study type

Observational

Funder types

Industry

Identifiers

NCT04416659
3002

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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