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NCT04416659 Clinical Trial

Flow Arrest Safety and Technical Success With Balloon Guide Catheters

Acute Ischemic Stroke Clinical Trial

— FAST-BGC  

Official title:
Flow Arrest Safety and Technical Success With Balloon Guide Catheters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04416659
Other study ID # 3002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2021
Est. completion date October 27, 2021

Study information
Verified date April 2022
Source Medtronic Neurovascular Clinical Affairs
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date October 27, 2021
Est. primary completion date October 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Neuro-vascular access
Adjunctive device providing a conduit for retrieval device during thrombectomy

Locations
Country Name City State
United States Northwestern University Chicago Illinois
United States University of Missouri Columbia Missouri
United States Swedish-RIACO Englewood Colorado
United States Baptist Health Jacksonville Jacksonville Florida
United States KUMC Kansas City Kansas
United States Ft Sanders Regional Medical Center Knoxville Tennessee
United States BNI (St. Joseph's Hospital-Dignity Health) Phoenix Arizona
United States Carilion Clinic Roanoke Virginia
United States UMass Medical School Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Evaluation Incidence of device-related adverse events Hospital discharge or 7 days
Primary Performance Evaluation Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment Completion of procedure
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