A Study to Evaluate the Effects of the Neuroflo Device in People Who Have Had a Stroke - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Stroke	Device: NeuroFlo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Feasibility and Safety of NeuroFlo™ in Patients With Persistent Arterial Occlusion (PAO) After Failed Mechanical Revascularization

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Mortality and neurological deterioration at 5 days post treatment [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in neurological status and adverse events from baseline through 30 days from treatment [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
Change in neurological status and adverse events from baseline through 90 days from treatment [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Intervention Details:

The device will be inflated for 45 minutes in acute ischemic stroke patients who have failed mechanical recanalization.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653536

Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

CoAxia

Investigators

Principal Investigator:	David S. Liebeskind, M.D.	University of California, Los Angeles
Principal Investigator:	Sidney Starkman, M.D.	University of California, Los Angeles

More Information

Additional Information:

UCLA Stroke Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	David Liebeskind, Professor of Neurology, Associate Neurology Director, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00653536 History of Changes
Other Study ID Numbers:	07-08-010
Study First Received:	April 2, 2008
Last Updated:	January 28, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

stroke
neuroflo
device
failure to recanalize

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 18, 2013

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