REperfusion With Cooling in CerebraL Acute IscheMia II "RECCLAIM-II"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female subjects of any ethnicity and age >/=18 but - Symptom onset - Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by CT imaging of the brain;
- Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
- Ability to undergo endovascular reperfusion therapy;
- No contraindications to general anesthesia, conscious sedation, or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
- A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
- Baseline CT scan shows no hemorrhage;
- National Institutes of Health Stroke Scale (NIHSS) 14-29;
- Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy;
- Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities.
- Subject or legally authorized representative must be able to understand and give written informed consent.

Exclusion Criteria

- Females of childbearing potential who are pregnant or not using adequate contraception;
- Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.7 or any active or recent (within 10 to 30 days) hemorrhage;
- History of genetically confirmed hypercoagulable syndrome;
- Any condition that excludes MRI imaging;
- History of dementia, currently on Aricept or Namenda, or other Alzheimer's-like symptoms;
- End stage renal disease on hemodialysis;
- History of cardiac arrest;
- Presence of an inferior vena cava (IVC) filter;
- Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
- Known allergy to meperidine or buspar;
- Prior neurologic event that would obscure interpretation of the signal and current presenting neurologic deficits;
- Sustained hypertension (systolic blood pressure (SBP) > 185 or diastolic blood pressure (DBP) > 110 refractory to treatment);
- Baseline CT/MRI of head showing evidence of mass effect with mid-line shift, hemorrhage, intracranial tumor, arterial vasculitis or dissection, or bilateral stroke;
- Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit subject cooperation or study compliance;
- Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next 3 months;
- Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study.