A Study to Evaluate the Effects of the Neuroflo Device in People Who Have Had a Stroke (PAO)
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 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|
- Mortality and neurological deterioration at 5 days post treatment [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]
- 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 ]
|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)|
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.
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||David S. Liebeskind, M.D.||University of California, Los Angeles|
|Principal Investigator:||Sidney Starkman, M.D.||University of California, Los Angeles|