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

April 21, 2022 updated by: Medtronic Neurovascular Clinical Affairs
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • BNI (St. Joseph's Hospital-Dignity Health)
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Swedish-RIACO
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Health Jacksonville
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • KUMC
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Medical School
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
    • Tennessee
      • Knoxville, Tennessee, United States, 37902
        • Ft Sanders Regional Medical Center
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ischemic stroke

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Investigators

  • Principal Investigator: Biraj Patel, MD, Carilion Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

October 27, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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