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OpenTrials
Completed

NCT Number: NCT04416659

Flow Arrest Safety and Technical Success With Balloon Guide Catheters

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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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BNI (St. Joseph's Hospital-Dignity Health), Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuro-vascular access

Device

Adjunctive device providing a conduit for retrieval device during thrombectomy

Primary outcomes

  1. Safety Evaluation

    Time frame: Hospital discharge or 7 days

    Incidence of device-related adverse events

  2. Performance Evaluation

    Time frame: Completion of procedure

    Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Acronym: FAST-BGC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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