A Study to Evaluate the Effects of the Neuroflo Device in People Who Have Had a Stroke (PAO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00653536|
Recruitment Status : Withdrawn (No Patients enrolled; sponsor not providing devices anymore)
First Posted : April 7, 2008
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Device: NeuroFlo||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Safety of NeuroFlo™ in Patients With Persistent Arterial Occlusion (PAO) After Failed Mechanical Revascularization|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
- Mortality and neurological deterioration at 5 days post treatment [ Time Frame: day 5 ]
- Change in neurological status and adverse events from baseline through 30 days from treatment [ Time Frame: Day 30 ]
- Change in neurological status and adverse events from baseline through 90 days from treatment [ Time Frame: 90 days ]
- Incidence of hemorrhagic transformation or other intracerebral bleeding at 5 days post treatment [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653536
|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|