A Study to Evaluate the Effects of the Neuroflo Device in People Who Have Had a Stroke(PAO)
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Status:
This study is currently recruiting participants.
Purpose:
To determine if improved regional perfusion leads to clinical improvement.
Interventions:
NeuroFlo
a device for augmenting the blood flow to the brain, and in particular to increase blood flow in the collateral blood vessels to augment perfusion in the ischemic penumbra.
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Year Started:
2008
Design:
Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study.
Inclusion Criteria
Acute cerebral ischemia due to occlusion of the internal carotid or middle cerebral artery; NIHSS 5-25 (inclusive);
persistent arterial occlusion (defined as TICI 0 or 1) following attempted thrombectomy with the Merci® Retriever System; able to undergo NeuroFlo treatment within 18 hours of symptom onset (or from last time known normal); negative pregnancy test in females of child-bearing potential.
Exclusion Criteria
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; 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 24 mm or smaller than 12 mm in diameter measured within 6 cm above and below the midpoint of the renal ostia; evidence of aortic aneurysm; high-grade iliac stenosis or vascular tortuosity that could prevent safe delivery and/or positioning of the NeuroFlo catheter.
Patient Involvement:
Patient 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. 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.
Primary Outcome:
Mortality and neurological deterioration at 5 days post treatment
Secondary Outcome:
Change in neurological status and adverse events from baseline through 30 days from treatment; change in neurological status and adverse events from baseline through 90 days from treatment; incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment; 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.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 9/14/2009
Reviewed on: 08/18/2009.
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