Ischemic StrokePhase 1FASTFlo tPANCT01006993
Feasibility and Safety of NeuroFlo in Stroke Patients Receiving Tissue Plasminogen Activator
A Phase 1 study testing NeuroFlo catheter in people with Ischemic Stroke, run by CoAxia at 4 sites in 2 countries.
Trial summary
To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- NeuroFlo catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2007to Jan 2010
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke
- NIHSS between 5-22
- Persistent clinical deficits following administration of rt-PA
Who cannot join
- Planned thrombectomy
- Aortic pathology
- Severe heart disease
- Other conditions the doctor will assess
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
University of Western Ontario
London, Ontario, N6A 5A5
Trillium Health Centre
Mississauga, Ontario, L5B 4A2
About this study
Official title: Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA
To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.
- Conditions
- Ischemic Stroke
- Being tested
- NeuroFlo catheter
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroFlo catheterDevice
NeuroFlo™ catheter 45 minute treatment
| Study group | Role | What they receive |
|---|---|---|
| NeuroFlo Treatment | Experimental | Not described Receives: Device: NeuroFlo catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.
Measured: Baseline to 30 days post-treatment
Secondary outcomes (1)
Potential patient benefit will be assessed through collection of neurological indices.
Measured: Baseline through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startMay 2007
- Primary completionJul 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoAxia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- FASTFlo Steering Committee, Study director, Various
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006993
- Sponsor's protocol ID
- CD-0258
- Acronym
- FASTFlo tPA
- Status last verified
- Mar 2010
- First submitted
- 2 Nov 2009
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Emery DJ, Schellinger PD, Selchen D, Douen AG, Chan R, Shuaib A, Butcher KS. Safety and feasibility of collateral blood flow augmentation after intravenous thrombolysis. Stroke. 2011 Apr;42(4):1135-7. doi: 10.1161/STROKEAHA.110.607846. Epub 2011 Feb 24.
PubMed 21350210
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of NeuroFlo in Stroke Patients Receiving tPA
- ClinicalTrials.gov ID
- NCT01006993
- Acronym / sponsor ID
- FASTFlo tPA / CD-0258
- Conditions
- Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CoAxiaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Nov 2009 (estimated)
- 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.
To assess the safety and feasibility of using the NeuroFlo catheter to treat acute ischemic stroke patients following administration of intravenous tPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuroFlo Treatment | Experimental | Device: NeuroFlo catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic stroke
- NIHSS between 5-22
- Persistent clinical deficits following administration of rt-PA
Key exclusion criteria (4 listed)
- Planned thrombectomy
- Aortic pathology
- Severe heart disease
- Other conditions the doctor will assess
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 |
|---|---|---|
| NeuroFlo catheterNeuroFlo™ catheter 45 minute treatment | Device | NeuroFlo Treatment |
Primary outcome
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment.
Time frame: Baseline to 30 days post-treatment
1 secondary outcome
Potential patient benefit will be assessed through collection of neurological indices.
Time frame: Baseline through 90 days
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 11 Mar 2010.
- Derived from this study: PubMed 21350210Emery DJ, Schellinger PD, Selchen D, Douen AG, Chan R, Shuaib A, Butcher KS. Safety and feasibility of collateral blood flow augmentation after intravenous thrombolysis. Stroke. 2011 Apr;42(4):1135-7. doi: 10.1161/STROKEAHA.110.607846. Epub 2011 Feb 24.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
FASTFlo Steering Committee study director
Various
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NeuroFlo catheter in people with Ischemic Stroke, run by CoAxia at 4 sites in 2 countries.
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 11 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
An assessment of serious adverse events occurring in ischemic stroke patients undergoing NeuroFlo treatment. (time frame: Baseline to 30 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01006993, which also lists 1 linked publication.
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 11 Mar 2010.