A Study to Evaluate the Effects of the Neuroflo Device in People Who Have Had a Stroke "PAO"


Phase 1 Results N/A

Eligibility Criteria

Inclusion Criteria

- 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

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 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