Flow Arrest Safety and Technical Success With Balloon Guide Catheters
FAST-BGC
1 other identifier
observational
52
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2021
CompletedApril 28, 2022
April 1, 2022
10 months
May 21, 2020
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Safety Evaluation
Incidence of device-related adverse events
Hospital discharge or 7 days
Performance Evaluation
Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment
Completion of procedure
Interventions
Adjunctive device providing a conduit for retrieval device during thrombectomy
Eligibility Criteria
Patients with acute ischemic stroke
You may qualify if:
- 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
You may not qualify if:
- Posterior circulation stroke
- Tandem occlusions
- Cervical carotid stenosis
- Participating in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
BNI (St. Joseph's Hospital-Dignity Health)
Phoenix, Arizona, 85013, United States
Swedish-RIACO
Englewood, Colorado, 80112, United States
Baptist Health Jacksonville
Jacksonville, Florida, 32207, United States
Northwestern University
Chicago, Illinois, 60611, United States
KUMC
Kansas City, Kansas, 66160, United States
UMass Medical School
Worcester, Massachusetts, 01655, United States
University of Missouri
Columbia, Missouri, 65212, United States
Ft Sanders Regional Medical Center
Knoxville, Tennessee, 37902, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Biraj Patel, MD
Carilion Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Week
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2020
First Posted
June 4, 2020
Study Start
January 12, 2021
Primary Completion
October 27, 2021
Study Completion
October 27, 2021
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
No IPD will be available.