Acute Ischemic StrokeFAST-BGCNCT04416659
Flow Arrest Safety and Technical Success With Balloon Guide Catheters
An observational study of Acute Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Neuro-vascular access
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Jan 2021to 27 Oct 2021
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke
Who may be able to join
- 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
Who cannot join
- Posterior circulation stroke
- Tandem occlusions
- Cervical carotid stenosis
- Participating in another clinical trial
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Northwestern University
Chicago, Illinois, 60611
University of Missouri
Columbia, Missouri, 65212
Swedish-RIACO
Englewood, Colorado, 80112
Baptist Health Jacksonville
Jacksonville, Florida, 32207
KUMC
Kansas City, Kansas, 66160
Ft Sanders Regional Medical Center
Knoxville, Tennessee, 37902
BNI (St. Joseph's Hospital-Dignity Health)
Phoenix, Arizona, 85013
Carilion Clinic
Roanoke, Virginia, 24014
UMass Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Neuro-vascular access
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-vascular accessDevice
Adjunctive device providing a conduit for retrieval device during thrombectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
Incidence of device-related adverse events
Measured: Hospital discharge or 7 days
Performance Evaluation
Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment
Measured: Completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start12 Jan 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biraj Patel, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416659
- Sponsor's protocol ID
- 3002
- Acronym
- FAST-BGC
- Status last verified
- Apr 2022
- First submitted
- 21 May 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Arrest Safety and Technical Success With Balloon Guide Catheters
- ClinicalTrials.gov ID
- NCT04416659
- Acronym / sponsor ID
- FAST-BGC / 3002
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Posterior circulation stroke
- Tandem occlusions
- Cervical carotid stenosis
- Participating in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-vascular accessAdjunctive device providing a conduit for retrieval device during thrombectomy | Device | – |
Primary outcome
Safety Evaluation
Time frame: Hospital discharge or 7 days
Incidence of device-related adverse events
Performance Evaluation
Time frame: Completion of procedure
Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No. No IPD will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biraj Patel, MD principal investigator
Carilion Clinic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation (time frame: Hospital discharge or 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.