Clinical trial NCT01584609: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke From Large Vessel Occlusion
Keywords: ischemic stroke
large vessel occlusion
mechanical thrombectomy
revascularization
Penumbra System
Separator 3D
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Angiographic Revascularization of the Occluded Target Vessel
timeFrame: At immediate post-procedure
measure: Number of Device-related Serious Adverse Events
timeFrame: Within 24 hours post-procedure
measure: Number of Procedure-related Serious Adverse Event
timeFrame: Within 24 hours post-procedure
Secondary outcomes:
measure: Good Clinical Outcome at 30 Days
timeFrame: 30 days post-procedure
measure: Number of Participants With 90 Day mRS Score 0-2
timeFrame: at 90 days post-procedure
measure: All Cause Mortality
timeFrame: At 90 days post-procedure
measure: Number of Symptomatic Intracranial Hemorrhage
timeFrame: Within 24 hours post-procedure
measure: Good Neurological Outcome at 90 Days
timeFrame: At 90 days post-procedure
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Denver
country: United States
facility: Swedish Medical Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Saint Paul
country: United States
facility: St. Joseph Hospital- Healtheast
state: Minnesota
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Swedish Medical Center, Denver, CO
name: Don Frei, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.