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

Status:	Completed
Conditions:	Peripheral Vascular Disease, Neurology
Therapuetic Areas:	Cardiology / Vascular Diseases, Neurology
Healthy:	No
Age Range:	18 - 85
Updated:	9/15/2018
Start Date:	April 2012
End Date:	December 2017

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

We found this trial at

sites

Kaleida Health

3 Gates Circle
Buffalo, New York 14209

716-887-4219