Cerebrovascular AccidentPhase 1Flo 24NCT00436592
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
A Phase 1 study testing NeuroFlo™ Catheter in people with Cerebrovascular Accident, run by CoAxia at 10 sites in 4 countries.
Trial summary
The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebrovascular Accident
- 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
- 26 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Feb 2007to Jan 2009
- 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 4-20
- Time from symptom onset between 8 and 24 hours
Who cannot join
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27514
UCLA
Los Angeles, California, 90024
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14642
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 2T9
University of Alberta
Edmonton, Alberta, T6G 2B7
About this study
The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.
Read the detailed description
The study is a prospective, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours.
A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian \& European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.
- Conditions
- Cerebrovascular Accident
- Being tested
- NeuroFlo™ Catheter
- Keywords
- acute, ischemic, stroke, device, treatment
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroFlo™ CatheterDevice
45 minute Treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: NeuroFlo™ Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of all adverse events from baseline to 30 days post-treatment.
Measured: 30 Days
Secondary outcomes (2)
Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.
Measured: 90 Days
Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.
Measured: ≤ 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2009
- Study completionJan 2009
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 Cerebrovascular AccidentStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoAxia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Flo 24 Steering Committee, Study chair, Multiple Organizations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436592
- Sponsor's protocol ID
- CD-0240
- Acronym
- Flo 24
- Status last verified
- Feb 2009
- First submitted
- 16 Feb 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hammer MD, Schwamm L, Starkman S, Schellinger PD, Jovin T, Nogueira R, Burgin WS, Sen S, Diener HC, Watson T, Michel P, Shuaib A, Dillon W, Liebeskind DS. Safety and feasibility of NeuroFlo use in eight- to 24-hour ischemic stroke patients. Int J Stroke. 2012 Dec;7(8):655-61. doi: 10.1111/j.1747-4949.2011.00719.x. Epub 2012 Jan 20.
PubMed 22264202
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
- ClinicalTrials.gov ID
- NCT00436592
- Acronym / sponsor ID
- Flo 24 / CD-0240
- Conditions
- Cerebrovascular Accident
- Keywords
- acute, ischemic, stroke, device, treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CoAxiaIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Feb 2007 (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.
The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.
Detailed description
The study is a prospective, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours.
A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian \& European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | 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 4-20
- Time from symptom onset between 8 and 24 hours
Key exclusion criteria (4 listed)
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney 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™ Catheter45 minute Treatment | Device | 1 |
Primary outcome
Assessment of all adverse events from baseline to 30 days post-treatment.
Time frame: 30 Days
2 secondary outcomes
Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.
Time frame: 90 Days
Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.
Time frame: ≤ 4 hours
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 5 Feb 2009.
- Derived from this study: PubMed 22264202Hammer MD, Schwamm L, Starkman S, Schellinger PD, Jovin T, Nogueira R, Burgin WS, Sen S, Diener HC, Watson T, Michel P, Shuaib A, Dillon W, Liebeskind DS. Safety and feasibility of NeuroFlo use in eight- to 24-hour ischemic stroke patients. Int J Stroke. 2012 Dec;7(8):655-61. doi: 10.1111/j.1747-4949.2011.00719.x. Epub 2012 Jan 20.
- Related InfoLink provided by the sponsor.
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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.
Flo 24 Steering Committee study chair
Multiple Organizations
10 sites in 4 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 Cerebrovascular Accident, run by CoAxia at 10 sites in 4 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 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Germany, Switzerland. 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?
Assessment of all adverse events from baseline to 30 days post-treatment. (time frame: 30 Days). 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 NCT00436592, 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 5 Feb 2009.