Status:
WITHDRAWN
A Study to Evaluate the Effects of the Neuroflo Device in People Who Have Had a Stroke
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
CoAxia
Conditions:
Acute Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00653536
Start Date
March 1 2008
End Date
January 1 2013
Last Update
January 12 2017
Active Locations (1)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095