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

NCT00653536 | Withdrawn Phase 1 DMC

• 1 other identifier: 07-08-010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Stroke

Keywords

stroke; neuroflo; device; failure to recanalize

Outcome Measures

Primary Outcomes (1)

• Mortality and neurological deterioration at 5 days post treatment

  day 5

Secondary Outcomes (4)

• Change in neurological status and adverse events from baseline through 30 days from treatment

  Day 30

• Change in neurological status and adverse events from baseline through 90 days from treatment

  90 days

• Incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment

  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

  3 hr and 24 hr

Interventions

NeuroFlo DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• CoAxia: collaborator

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David S. Liebeskind, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Sidney Starkman, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Associate Neurology Director

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

US (1)