This trial is active, not recruiting.

Condition acute ischemic stroke from large vessel occlusion
Treatments penumbra system with separator 3d, penumbra system alone
Phase phase 2/phase 3
Sponsor Penumbra Inc.
Start date April 2012
End date December 2016
Trial size 230 participants
Trial identifier NCT01584609, CLP 4853


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
penumbra system with separator 3d
The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
(Active Comparator)
penumbra system alone
The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.

Primary Outcomes

Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI score of 2 or 3
time frame: At immediate post-procedure
Incidence of device-related and procedure-related serious adverse event
time frame: Within 24 hours post-procedure

Secondary Outcomes

Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1at Discharge; or a 30-day mRS score of 0-2
time frame: 30 days post-procedure
The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2 at 90 days post procedure
time frame: at 90 days post-procedure
All cause mortality
time frame: At 90 days post-procedure
Incidence of symptomatic intracranial hemorrhage
time frame: At 90 days post-procedure
Good neurological outcome at 90 days post-procedure as defined by an mRS score of ≤ 2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an 10 or more points improvement on the NIHSS score
time frame: At 90 days post-procedure

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title 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
Principal investigator Don Frei, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Penumbra Inc..