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

Not Applicable

Completed

Interventions: Device: Penumbra System with Separator 3D
Device: Penumbra System alone

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Penumbra System with Separator 3D	Penumbra System with Separator 3D	-
Penumbra System alone	Penumbra System alone	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel	At immediate post-procedure	Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
Number of Device-related Serious Adverse Events	Within 24 hours post-procedure
Number of Procedure-related Serious Adverse Event	Within 24 hours post-procedure

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality	At 90 days post-procedure
Number of Symptomatic Intracranial Hemorrhage	Within 24 hours post-procedure
Good Clinical Outcome at 30 Days	30 days post-procedure	Defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1 at Discharge; or a 30-day mRS score of 0-2. The NIHSS is a stroke scale that measures impairment caused by stroke. The Modified Rankin scale (mRS) measures neurological disability or dependence for stroke patients.
Number of Participants With 90 Day mRS Score 0-2	at 90 days post-procedure
Good Neurological Outcome at 90 Days	At 90 days post-procedure	Defined by an mRS score of 0-2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an improvement of 10 or more points on the NIHSS score

Locations (8): Hoag Hospital
🇺🇸
Newport Beach, California, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Stony Brook University Hospital
🇺🇸
Stony Brook, New York, United States
Grady Health System
🇺🇸
Atlanta, Georgia, United States
St. Joseph Hospital- Healtheast
🇺🇸
Saint Paul, Minnesota, United States
Kaleida Health
🇺🇸
Buffalo, New York, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Swedish Medical Center
🇺🇸
Denver, Colorado, United States