ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

This is an interventional treatment trial for Ischemic Stroke focused on measuring Acute ischemic stroke Read More

Inclusion Criteria:

• Age ≥ 22 and ≤ 85 years
• Clinical signs consistent with the diagnosis of acute ischemic stroke
• Pre-stroke Modified Rankin Score ≤2
• National Institute of Health Stroke Scale (NIHSS) assessment score ≥8 and <30
• Patient presents between 0 and 8 hours of onset of stroke symptoms
• Contraindicated for IV t-PA treatment (as specified by drug manufacturer's IFU) OR Acute ischemic stroke treated with intravenous thrombolytic therapy where vascular imaging (TCD, CTA, MRA, or angiography) shows a persistent occlusion after the end of the infusion treatment. NOTE:
• Treatment initiated within 8 hours after symptom onset (first retrieval pass made within 8 hours)
• Neurologic signs that are NOT rapidly improving (NIHSS score has NOT decreased by 4 or more points as determined prior to or at the time of treatment as compared to the initial screen;
• TIMI 0 or 1 flow in internal carotid, middle cerebral M1/M2 segments, basilar, or vertebral arteries confirmed by angiography which are accessible to the retrieval devices.
• Patient/patient legal authorized representative willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations
• Patient or legally authorized representative has given informed consent, and consent is documented.

Exclusion Criteria:

• NIHSS ≥30 or comatose
• Known to be pregnant
• Serum glucose level <50 mg/dL
• Excessive cervical arterial tortuousity that prevents placement of the retrieval devices
• Known hemorrhagic diathesis
• Patients exhibiting signs suggestive of or angiographic evidence of bilateral stroke
• Coagulation factor deficiency (or oral anticoagulation therapy with INR>3.0)
• In receipt of heparin within 48 hours with a PTT > 2x the lab normal
• Baseline platelets <30,000 mm3
• Known serious sensitivity to intra-arterial radiographic contrast agents
• Severe sustained hypertension (systolic blood pressure > 185 mmHg or diastolic >110 mmHg)
• Baseline CT or MRI revealed significant mass effect with midline shift or greater than 1/3 of the MCA region with hypodensity (sulcal effacement and/or loss of gray-white differentiation is allowed)
• Neurologic signs that are rapidly improving at the time of treatment as measured by a decrease in NIHSS score of 4 or more points as determined prior to or at the time of treatment as compared to the initial screen
• CT or MRI evidence of hemorrhage on presentation
• CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
• Life expectancy < 3 months
• Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or vasculitis
• At the discretion of the investigator, patients with co-morbidities associated with a life expectancy of less than 3 months or co-morbidities that could influence the study results or make clinical follow-up difficult will be excluded.