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| ID | Type | Description | Link |
|---|---|---|---|
| CLP 4853 | Other Identifier | Penumbrainc |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penumbra System with Separator 3D | Experimental |
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| Penumbra System alone | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penumbra System with Separator 3D | Device | The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Angiographic Revascularization of the Occluded Target Vessel | Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3 | At immediate post-procedure |
| Number of Device-related Serious Adverse Events | Within 24 hours post-procedure | |
| Number of Procedure-related Serious Adverse Event | Within 24 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Good Clinical Outcome at 30 Days | 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. | 30 days post-procedure |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Don Frei, MD | Swedish Medical Center, Denver, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Hospital | Newport Beach | California | 92658 | United States | ||
| Swedish Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29296999 | Derived | Nogueira RG, Frei D, Kirmani JF, Zaidat O, Lopes D, Turk AS 3rd, Heck D, Mason B, Haussen DC, Levy EI, Mehta S, Lazzaro M, Chen M, Dorfler A, Yoo AJ, Derdeyn CP, Schwamm L, Langer D, Siddiqui A; Penumbra Separator 3D Investigators. Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial. JAMA Neurol. 2018 Mar 1;75(3):304-311. doi: 10.1001/jamaneurol.2017.3967. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Penumbra System With Separator 3D | Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System. |
| FG001 | Penumbra System Alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2012 | Apr 20, 2018 |
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| Penumbra System alone | Device | 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. |
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| Number of Participants With 90 Day mRS Score 0-2 | at 90 days post-procedure |
| All Cause Mortality | At 90 days post-procedure |
| Number of Symptomatic Intracranial Hemorrhage | Within 24 hours post-procedure |
| Good Neurological Outcome at 90 Days | 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 | At 90 days post-procedure |
| Denver |
| Colorado |
| 80112 |
| United States |
| Hartford Hospital | Hartford | Connecticut | 6106 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| St. Joseph Hospital- Healtheast | Saint Paul | Minnesota | 55102 | United States |
| Kaleida Health | Buffalo | New York | 14209 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794-8122 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Penumbra System With Separator 3D | Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System. |
| BG001 | Penumbra System Alone | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Angiographic Revascularization of the Occluded Target Vessel | Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3 | Analysis population demonstrate outcomes of number of subjects that met endpoint. | Posted | Count of Participants | Participants | At immediate post-procedure |
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| Primary | Number of Device-related Serious Adverse Events | Posted | Number | Device-Related Serious Adverse Events | Within 24 hours post-procedure |
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| Primary | Number of Procedure-related Serious Adverse Event | Posted | Number | Procedure-related Serious Adverse Events | Within 24 hours post-procedure |
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| Secondary | Good Clinical Outcome at 30 Days | 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. | Analysis population demonstrate outcomes of number of subjects that met endpoint. | Posted | Count of Participants | Participants | 30 days post-procedure |
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| Secondary | Number of Participants With 90 Day mRS Score 0-2 | Posted | Count of Participants | Participants | at 90 days post-procedure |
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| Secondary | All Cause Mortality | Posted | Count of Participants | Participants | At 90 days post-procedure |
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| Secondary | Number of Symptomatic Intracranial Hemorrhage | Posted | Number | Symptomatic Intracranial Hemorrhage | Within 24 hours post-procedure |
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| Secondary | Good Neurological Outcome at 90 Days | 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 | Posted | Count of Participants | Participants | At 90 days post-procedure |
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Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Penumbra System With Separator 3D | Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System. | 19 | 98 | 38 | 88 | 81 | 88 |
| EG001 | Penumbra System Alone | 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. | 26 | 100 | 49 | 93 | 83 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Endocrine disorders | Endocrine disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Immune system disorders | Immune system disorders | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Infections and Infestations | Infections and infestations | Systematic Assessment |
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| Vascular Disorder | Vascular disorders | Systematic Assessment |
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| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
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| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michaella Corso | Penumbra, Inc. | (510) 748-3200 | mcorso@penumbrainc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2013 | May 16, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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