IRB Number
|
# 25494
|
| Description |
Patients with acute ischemic stroke are randomized to receive either
standard of care or a dual balloon catheter device temporarily inflated in
the lower aorta in order to increase blood flow to the brain. Procedure
takes less than one hour and may reduce brain damage and/or help recovery
after stroke. |
| What is expected of me? |
Permit an aortagram and possible device placement; labs to be drawn; their
data to be collected; and return for their standard care visits post
treatment. |
| Inclusion Criteria |
Age ≥ 18 years, acute cerebral ischemia with baseline evaluation within 10
hrs of symptom onset & NIHSS 5 to 18. |
| Exclusion Criteria |
Major exclusions: any hemorrhage, pregnancy, previous stroke with deficit,
rapidly improving neurologic status, use of rt-PA or clot retrieval device
/catheter, uncontrolled blood pressure, unsecured cerebral aneurysm or
history of intracranial bleed, CHF, recent MI, Class III or IV angina, acute
MI & aortic aneurysm (corrected or uncorrected). |
| Length of Study |
90 days |
| Study Location |
Penn
State Hershey Medical Center |
| Investigator Information |
Kevin Cockroft, MD, Neurosurgery |
| To obtain more information about this study please contact: |
Deborah Hoffman, RN, CCRC
717 531 0003 x 283063;
dhoffman1@hmc.psu.edu |
