Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy "MR RESCUE"


Phase 2 Results

Eligibility Criteria

Inclusion Criteria

- New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS >/= 6)
- Age >/= 18 ≤ 85
- Clot retrieval procedure can be initiated within 8 hours from onset
- Large vessel proximal anterior circulation occlusion on MR or CT angiography (internal carotid, M1 or M2 MCA)
- Pretreatment MRI performed according to MR RESCUE protocol
- Signed informed consent obtained from the patient or patient's legally authorized representative
- Premorbid modified Rankin score of 0-2
- Allowed but not required: patients treated with IV tPA (tissue plasminogen activator) up to 4.5 hours from symptom onset with persistent target occlusion on post-treatment MR RESCUE MR or CT protocol performed at the completion of drug infusion (Note: Rapidly improving neurological signs prior to randomization is an exclusion)

Exclusion Criteria

- NIHSS >/= 30
- Contraindication to MRI (pacemaker etc)
- Acute intracranial hemorrhage
- Coma
- Rapidly improving neurological signs prior to randomization
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- Pregnancy
- Known allergy to iodine previously refractory to pretreatment medications
- Current participation in another experimental treatment protocol
- Contrast-Enhanced Neck MRA (magnetic resonance angiography) or CTA (computed tomography angiography) suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection
- INR > 3.0 (international normalized ratio)
- PTT > 3 x Normal (partial thromboplastin time)
- Imaging data cannot be processed by the MR RESCUE computer
- Renal Failure (serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30)
MRI Exclusion Criteria:
- Contraindication to MRI (pacemaker, etc)
CT Exclusion Criteria:
- Contraindication to iodinated contrast**
**Examples of possible iodinated contrast contraindications include:
- Hyperthyroidism
- History of severe allergic reaction to iodinated contrast material
- History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
- Paraproteinemia syndromes or multiple myeloma
- Collagen vascular disease
- Severe cardiac insufficiency
- Severely compromised liver function
- Current therapy with metformin, aminoglycosides