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 currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
First received: April 23, 2012
Last updated: November 6, 2014
Last verified: November 2014

This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm 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 164 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 TIMI/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: During the 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) of ≤ 2 at 90 days post treatment [ 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 hemorrhage [ Time Frame: At 90 days post-procedure ] [ Designated as safety issue: Yes ]

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.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  • Evidence of a large vessel (3mm 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 PPT >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

Contact: Elan Mualem, BS 510-748-3254 elan.mualem@penumbrainc.com
Contact: Siu P Sit, PhD 510-748-3221 siupo.sit@penumbrainc.com

United States, California
Hoag Hospital Recruiting
Newport Beach, California, United States, 92658
Contact: Laura Whitaker    949-764-8190    laura.whitaker@hoaghospital.org   
Contact: Wallace Peck, MD    949-764-8190    wpneurorad@aol.com   
Principal Investigator: Wallace Peck, MD         
United States, Colorado
Swedish Medical Center Recruiting
Denver, Colorado, United States, 80112
Contact: Gwen Dooley    303-757-3525    Gwendolyn.dooley@riaco.com   
Contact: Ita Dempsey, RN    720-493-3406    don.frei@riaco.com   
Principal Investigator: David Loy, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 6106
Contact: Martha Ahlquist    860-545-6047    Mahlqui@harthosp.org   
Contact: Linda Adams    860-545-5611    ladams@harthosp.org   
Principal Investigator: Gary Spiegel, MD         
Sub-Investigator: Stephen Ohki, MD         
Sub-Investigator: Martin Ollenschleger, MD         
United States, Georgia
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Kiva Schindler, RN, CCRC    404-778-1571    kiva.m.schindler@emory.edu   
Principal Investigator: Raul Nogueira, MD         
Sub-Investigator: Rishi Gupta, MD         
United States, Minnesota
St. Joseph Hospital- Healtheast Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Sandy Bartz    651-726-6458    sbartz@stpaulrad.com   
Contact: Michael Madison, MD    612-860-2436    mmadison@stpaulrad.com   
Principal Investigator: Michael Madison, MD         
United States, New York
Kaleida Health Recruiting
Buffalo, New York, United States, 14209
Contact: Jennifer Gay    716-218-1000 ext 5111    jgay@ubns.com   
Principal Investigator: Adnan Siddiqui, MD/PhD         
Sub-Investigator: Elad Levy, MD         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794-8122
Contact: Marlene Baumeister, RN, BSN, CCRC, CNRN    631-444-1610    mbaumeister@notes.cc.sunysb.edu   
Contact: Dawn Madigan, RN, BSN,CCRC    631-444-8121    Dawn.Madigan@sbumed.org   
Principal Investigator: David Fiorella, MD         
Principal Investigator: Henry Woo, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Bree Burks    615-875-7606    bree.burks@Vanderbilt.Edu   
Principal Investigator: J Mocco, MD         
Sponsors and Collaborators
Penumbra Inc.
Principal Investigator: Don Frei, MD Swedish Medical Center, Denver, CO
  More Information

No publications provided

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: November 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Penumbra Inc.:
ischemic stroke
large vessel occlusion
mechanical thrombectomy
Penumbra System
Separator 3D

Additional relevant MeSH terms:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 30, 2015