A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.

Inclusion Criteria:

• From 18 to 85 years of age
• Present with symptoms consistent with an acute ischemic stroke for revascularization within 8 hours from symptom onset
• Refractory to or not eligible for IV rtPA therapy., e.g., presenting between 0 and 3 hours from symptom onset AND contraindicated for IV rtPA, or presenting between 3 and 8 hours of symptom onset, or evidence of persistent occlusion from vascular imaging after IV rtPA
• Evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation
• NIH Stroke Scale (NIHSS) score 8 or more points
• Signed informed consent

Exclusion Criteria:

• History of stroke in the past 3 months.

• Females who are pregnant

• Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or higher

• Known severe allergy to contrast media

• Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)

• CT evidence of the following conditions at randomization:

  • Significant mass effect with midline shift
  • Large infarct region >1/3 of the middle cerebral artery territory
  • Evidence of intracranial hemorrhage

• Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal

• Angiographic evidence of preexisting arterial injury

• Rapidly improving neurological status prior to enrollment

• Bilateral stroke

• Intracranial tumors

• Known history of cerebral aneurysm or arteriovenous malformation

• Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7

• Baseline platelets <50,000

• Use of IV heparin in the past 48 hours with PTT >1.5 times the normalized ratio

• Baseline glucose <50mg/dL or >300mg/dL

• Life expectancy less than 90 days prior to stroke onset

• Participation in another clinical investigation that could confound the evaluation of the study device