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

January 11, 2017 updated by: David Liebeskind, University of California, Los Angeles

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.

Study Overview

Status

Withdrawn

Conditions

Acute Stroke

Intervention / Treatment

Device: NeuroFlo

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 Type

Interventional

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality and neurological deterioration at 5 days post treatment Time Frame: day 5	day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in neurological status and adverse events from baseline through 30 days from treatment Time Frame: Day 30	Day 30
Change in neurological status and adverse events from baseline through 90 days from treatment Time Frame: 90 days	90 days
Incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment Time Frame: day 5	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	3 hr and 24 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

UCLA Stroke Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)