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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 study is ongoing, but not recruiting participants.
Sponsor:
Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01584609
First received: April 23, 2012
Last updated: December 22, 2016
Last verified: December 2016
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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 Intervention Model: Parallel Assignment Masking: Single Blind (Participant) 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 ]
- Incidence of device-related and procedure-related serious adverse event [ Time Frame: Within 24 hours post-procedure ]
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 ]
- 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 ]
| Estimated Enrollment: | 230 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | June 2017 (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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
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 ( Other Identifier: Penumbrainc ) |
| Study First Received: | April 23, 2012 |
| Last Updated: | December 22, 2016 |
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 June 22, 2017