Acute StrokePhase 1PAONCT00653536
A Study to Evaluate the Effects of the Neuroflo Device in People Who Have Had a Stroke
A Phase 1 study testing NeuroFlo in people with Acute Stroke, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Patients with acute ischemic stroke and persistent arterial occlusion following failed mechanical revascularization, who can undergo NeuroFlo treatment within 18 hours of last time symptom free, will be eligible for enrollment to assess the safety and feasibility of the NeuroFlo catheter in treating ischemic stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- NeuroFlo
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Acute cerebral ischemia due to occlusion of the internal carotid or middle cerebral artery
- NIHSS 8-25 (inclusive)
- Persistent arterial occlusion (defined as TICI 0 or 1) following failed mechanical revascularization (ref Table 2)
- Able to undergo NeuroFlo treatment within 18 hours of symptom onset (or from last time known normal)
- Informed consent from patient or legally authorized representative
- Negative pregnancy test in females of child-bearing potential
Who cannot join
- Etiology other than cerebral ischemia
- Acute hypodense parenchymal lesion or effacement of cerebral sulci in more than 1/3 of the middle cerebral artery territory
- Brainstem or cerebellar stroke
- Systolic blood pressure (BP) >220 mm Hg, or diastolic (BP) >140 mm Hg that cannot be lowered with medical management
- Any use of intravenous or intra-arterial thrombolytic medication
- Known secured or unsecured cerebral aneurysm or vascular malformation on CTA or MRA or history thereof
Show all 27Show fewer
- Imaging evidence of current intracranial bleeding
- History of intracerebral hemorrhage
- Any aortic or femoral endovascular graft
- Aortic surgery within 6 weeks prior to the time of enrollment
- Known heparin sensitivity or allergy
- Participation in another therapeutic/treatment research protocol
- Any intracranial pathology interfering with the imaging assessments
- Current congestive or decompensated heart failure
- Known ejection fraction (EF) < 30% or evidence of NYHA Class IV or ACC/AHA Stage D heart failure within the past 3 months
- Known or echo evidence of aortic regurgitation ≥ 3+
- Myocardial infarction within last 3 months
- Evidence of acute MI on ECG or by cardiac enzymes
- Current or recent Class III or IV angina despite medical/surgical treatment
- INR > 1.7
- Platelet count < 100,000
- Creatinine > 1.5 times local laboratory standard
- Patients with cerebral arterial perforation or dissection due to attempted thrombectomy
- Patients with complications of femoral artery cannulation
- Patients with aortic diameter greater than 28 mm or smaller than 11 mm in diameter measured within 6 cm above and below the midpoint of the renal ostia (for 7Fr NeuroFlo Device)
- Evidence of aortic aneurysm
- High-grade iliac stenosis or vascular tortuosity that could prevent safe delivery and/or positioning of the NeuroFlo catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of NeuroFlo™ in Patients With Persistent Arterial Occlusion (PAO) After Failed Mechanical Revascularization
Patients with acute ischemic stroke and persistent arterial occlusion following failed mechanical revascularization, who can undergo NeuroFlo treatment within 18 hours of last time symptom free, will be eligible for enrollment to assess the safety and feasibility of the NeuroFlo catheter in treating ischemic stroke patients with persistent arterial occlusion following attempted thrombectomy. The NeuroFlo catheter is designed to partially obstruct the abdominal descending aorta thereby increasing blood flow to the brain. Cerebral perfusion is improved by diverting more blood through vessels as well as by expansion of the collateral circulation. Improved regional perfusion leads to clinical improvement.
Read the detailed description
Patients with occlusion of a proximal artery experience prompt diversion of flow through collaterals and retrograde perfusion of the occluded arterial tree. Collateral perfusion sustains the penumbra and may lessen stroke severity provided recanalization of the occluded artery occurs. Thrombectomy attempts to achieve recanalization of the occluded artery, but 36% of patients (90/252 in MERCI and MultiMERCI studies) experienced persistent arterial occlusion (PAO, defined as TICI flow 0-1). PAO following attempted thrombectomy was associated with high mortality, with 53% dead at 90 days. Of the survivors, only 5% achieved mRS of 0-2. At present, there are no therapies that have been shown to improve these risks. Data obtained from a clinically indicated CT at 24 hours will be used to monitor for safety.
The safety endpoints for this study will be the proportion of patients who experience:
- Mortality and neurological deterioration (defined as an increase of ≥4 points on the NIHSS) at 5 days post treatment
- Change in neurological status and adverse events from baseline through 30 days from treatment
Other endpoints include:
- Change in neurological status and adverse events from baseline through 90 days from treatment
- The incidence of hemorrhagic transformation or other intracerebral bleeding will be assessed at 5 days post treatment.
- Cerebral blood flow changes associated with device therapy will be assessed through multimodal CT or MRI studies acquired at baseline and 3 hours post treatment.
- Potential patient benefit will be assessed through collection of neurological indices (NIHSS etc.) at baseline, 24 hours post-procedure, day 5 (or discharge), 30 days and 90 days.
- Conditions
- Acute Stroke
- Being tested
- NeuroFlo
- Keywords
- stroke, neuroflo, device, failure to recanalize
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroFloDevice
The device will be inflated for 45 minutes in acute ischemic stroke patients who have failed mechanical recanalization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and neurological deterioration at 5 days post treatment
Measured: day 5
Secondary outcomes (4)
Change in neurological status and adverse events from baseline through 30 days from treatment
Measured: Day 30
Change in neurological status and adverse events from baseline through 90 days from treatment
Measured: 90 days
Incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment
Measured: day 5
Cerebral blood flow changes associated with device therapy assessed through multimodal MRI studies acquired at baseline and 3 hours post treatment obtained routinely at UCLA post IV or IA intervention in acute stroke patients
Measured: 3 hr and 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: No Patients enrolled; sponsor not providing devices anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- CoAxia
- Responsible party
- Principal investigator, David Liebeskind, University of California, Los Angeles
- Investigators
- David S. Liebeskind, M.D., Principal investigator, University of California, Los AngelesSidney Starkman, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653536
- Sponsor's protocol ID
- 07-08-010
- Acronym
- PAO
- Status last verified
- Jan 2017
- First submitted
- 2 Apr 2008
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of NeuroFlo™ in Patients With Persistent Arterial Occlusion (PAO) After Failed Mechanical Revascularization
- ClinicalTrials.gov ID
- NCT00653536
- Acronym / sponsor ID
- PAO / 07-08-010
- Conditions
- Acute Stroke
- Keywords
- stroke, neuroflo, device, failure to recanalize
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Patients enrolled; sponsor not providing devices anymore
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- CoAxia
- Study start
- Mar 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Apr 2008 (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.
Patients with acute ischemic stroke and persistent arterial occlusion following failed mechanical revascularization, who can undergo NeuroFlo treatment within 18 hours of last time symptom free, will be eligible for enrollment to assess the safety and feasibility of the NeuroFlo catheter in treating ischemic stroke patients with persistent arterial occlusion following attempted thrombectomy. The NeuroFlo catheter is designed to partially obstruct the abdominal descending aorta thereby increasing blood flow to the brain. Cerebral perfusion is improved by diverting more blood through vessels as well as by expansion of the collateral circulation. Improved regional perfusion leads to clinical improvement.
Detailed description
Patients with occlusion of a proximal artery experience prompt diversion of flow through collaterals and retrograde perfusion of the occluded arterial tree. Collateral perfusion sustains the penumbra and may lessen stroke severity provided recanalization of the occluded artery occurs. Thrombectomy attempts to achieve recanalization of the occluded artery, but 36% of patients (90/252 in MERCI and MultiMERCI studies) experienced persistent arterial occlusion (PAO, defined as TICI flow 0-1). PAO following attempted thrombectomy was associated with high mortality, with 53% dead at 90 days. Of the survivors, only 5% achieved mRS of 0-2. At present, there are no therapies that have been shown to improve these risks. Data obtained from a clinically indicated CT at 24 hours will be used to monitor for safety.
The safety endpoints for this study will be the proportion of patients who experience:
- Mortality and neurological deterioration (defined as an increase of ≥4 points on the NIHSS) at 5 days post treatment
- Change in neurological status and adverse events from baseline through 30 days from treatment
Other endpoints include:
- Change in neurological status and adverse events from baseline through 90 days from treatment
- The incidence of hemorrhagic transformation or other intracerebral bleeding will be assessed at 5 days post treatment.
- Cerebral blood flow changes associated with device therapy will be assessed through multimodal CT or MRI studies acquired at baseline and 3 hours post treatment.
- Potential patient benefit will be assessed through collection of neurological indices (NIHSS etc.) at baseline, 24 hours post-procedure, day 5 (or discharge), 30 days and 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Acute cerebral ischemia due to occlusion of the internal carotid or middle cerebral artery
- NIHSS 8-25 (inclusive)
- Persistent arterial occlusion (defined as TICI 0 or 1) following failed mechanical revascularization (ref Table 2)
- Able to undergo NeuroFlo treatment within 18 hours of symptom onset (or from last time known normal)
Key exclusion criteria (27 listed)
- Etiology other than cerebral ischemia
- Acute hypodense parenchymal lesion or effacement of cerebral sulci in more than 1/3 of the middle cerebral artery territory
- Brainstem or cerebellar stroke
- Systolic blood pressure (BP) >220 mm Hg, or diastolic (BP) >140 mm Hg that cannot be lowered with medical management
- Any use of intravenous or intra-arterial thrombolytic medication
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 |
|---|---|---|
| NeuroFloThe device will be inflated for 45 minutes in acute ischemic stroke patients who have failed mechanical recanalization. | Device | – |
Primary outcome
Mortality and neurological deterioration at 5 days post treatment
Time frame: day 5
4 secondary outcomes
Change in neurological status and adverse events from baseline through 30 days from treatment
Time frame: Day 30
Change in neurological status and adverse events from baseline through 90 days from treatment
Time frame: 90 days
Incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment
Time frame: day 5
Cerebral blood flow changes associated with device therapy assessed through multimodal MRI studies acquired at baseline and 3 hours post treatment obtained routinely at UCLA post IV or IA intervention in acute stroke patients
Time frame: 3 hr and 24 hr
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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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.
David S. Liebeskind, M.D. principal investigator
University of California, Los Angeles
Sidney Starkman, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NeuroFlo in people with Acute Stroke, run by University of California, Los Angeles at 1 site 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 7 inclusion and 27 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: withdrawn, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Mortality and neurological deterioration at 5 days post treatment (time frame: day 5). 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 12 Jan 2017.