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

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