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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

Primary Purpose

Acute Ischemic Stroke From Large Vessel Occlusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Penumbra System with Separator 3D
Penumbra System alone
Sponsored by
Penumbra Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke From Large Vessel Occlusion focused on measuring ischemic stroke, large vessel occlusion, mechanical thrombectomy, revascularization, Penumbra System, Separator 3D

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hoag Hospital
  • Swedish Medical Center
  • Hartford Hospital
  • Grady Health System
  • St. Joseph Hospital- Healtheast
  • Kaleida Health
  • Stony Brook University Hospital
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Penumbra System with Separator 3D

Penumbra System alone

Arm Description

Outcomes

Primary Outcome Measures

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
Number of Device-related Serious Adverse Events
Number of Procedure-related Serious Adverse Event

Secondary Outcome Measures

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.
Number of Participants With 90 Day mRS Score 0-2
All Cause Mortality
Number of Symptomatic Intracranial Hemorrhage
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

Full Information

First Posted
April 23, 2012
Last Updated
September 11, 2018
Sponsor
Penumbra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01584609
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke From Large Vessel Occlusion
Keywords
ischemic stroke, large vessel occlusion, mechanical thrombectomy, revascularization, Penumbra System, Separator 3D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Penumbra System with Separator 3D
Arm Type
Experimental
Arm Title
Penumbra System alone
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Penumbra System with Separator 3D
Intervention Description
The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
Intervention Type
Device
Intervention Name(s)
Penumbra System alone
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel
Description
Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
Time Frame
At immediate post-procedure
Title
Number of Device-related Serious Adverse Events
Time Frame
Within 24 hours post-procedure
Title
Number of Procedure-related Serious Adverse Event
Time Frame
Within 24 hours post-procedure
Secondary Outcome Measure Information:
Title
Good Clinical Outcome at 30 Days
Description
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.
Time Frame
30 days post-procedure
Title
Number of Participants With 90 Day mRS Score 0-2
Time Frame
at 90 days post-procedure
Title
All Cause Mortality
Time Frame
At 90 days post-procedure
Title
Number of Symptomatic Intracranial Hemorrhage
Time Frame
Within 24 hours post-procedure
Title
Good Neurological Outcome at 90 Days
Description
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
Time Frame
At 90 days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Frei, MD
Organizational Affiliation
Swedish Medical Center, Denver, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Swedish Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
6106
Country
United States
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
St. Joseph Hospital- Healtheast
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8122
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29296999
Citation
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.
Results Reference
derived

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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

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