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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Ischemic Stroke From Large Vessel Occlusion	Device: Penumbra System with Separator 3D Device: Penumbra System alone	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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

Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Incidence of device-related and procedure-related serious adverse event [ Time Frame: Within 24 hours post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: At 90 days post-procedure ] [ Designated as safety issue: Yes ]
Incidence of symptomatic intracranial hemorrhage [ Time Frame: At 90 days post-procedure ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	230
Study Start Date:	April 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Penumbra System with Separator 3D	Device: 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	Device: 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.

Arms

Assigned Interventions

Experimental: Penumbra System with Separator 3D

Device: 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

Device: 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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584609

Locations


United States, California
Hoag Hospital
Newport Beach, California, United States, 92658
United States, Colorado
Swedish Medical Center
Denver, Colorado, United States, 80112
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 6106
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
United States, Minnesota
St. Joseph Hospital- Healtheast
St. Paul, Minnesota, United States, 55102
United States, New York
Kaleida Health
Buffalo, New York, United States, 14209
Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8122
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Penumbra Inc.

Investigators


Principal Investigator:	Don Frei, MD	Swedish Medical Center, Denver, CO

More Information


Responsible Party:	Penumbra Inc.
ClinicalTrials.gov Identifier:	NCT01584609 History of Changes
Other Study ID Numbers:	CLP 4853 CLP 4853
Study First Received:	April 23, 2012
Last Updated:	March 14, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penumbra Inc.:


ischemic stroke large vessel occlusion mechanical thrombectomy	revascularization Penumbra System Separator 3D

Additional relevant MeSH terms:


Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction	Brain Ischemia Glucuronyl glucosamine glycan sulfate Anticoagulants Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Fibrinolytic Agents Fibrin Modulating Agents Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016