Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
Condition: Stroke
MeSH terms: Stroke
Intervention: Merci Retriever and Penumbra System
Intervention description: The MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Retriever consists of a flexible, nickel titanium (nitinol) wire with a helical-shaped distal tip. The helical distal tip is covered with a platinum radiopaque coil, which facilitates fluoroscopic visualization. The body of the MERCI Retriever is covered with a hydrophilic coating that helps facilitate device placement. The MERCI Retriever is available in 6 configurations (Merci Retrievers X6, L5, L4, L6, V series, DAC).
The Penumbra System uses a reperfusion catheter in parallel with a separator component and an aspiration source to achieve separation of the thrombus and subsequent aspiration of the occlusion from the vessel. The system is available in different sizes according to the target vessels (041 Reperfusion Catheter/Separator pair for use in vessels larger than 3mm, notably the ICA and M1; 032 Reperfusion Catheter/Separator pair for use in vessels 2mm - 3mm, notably the M2).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: stroke; ischemic stroke; blood clot; Merci Retriever; Penumbra System; embolectomy; magnetic resonance imaging; MRI; CT; SPOTRIAS

Summary:

      The purpose of this study is to compare the effectiveness of treating acute ischemic stroke
      with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours
      of symptom onset to standard medical treatment, and to identify people who might benefit from
      mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT)
      or magnetic resonance (MR) imaging.
    

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