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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 currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01584609
First received: April 23, 2012
Last updated: February 19, 2014
Last verified: February 2014

April 23, 2012
February 19, 2014
April 2012
December 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01584609 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Ischemic Stroke From Large Vessel Occlusion
  • Device: Penumbra System with Separator 3D
    The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
  • 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.
  • Experimental: Penumbra System with Separator 3D
    Intervention: Device: Penumbra System with Separator 3D
  • Active Comparator: Penumbra System alone
    Intervention: Device: Penumbra System alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
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
 
NCT01584609
CLP 4853, CLP 4853
Yes
Penumbra Inc.
Penumbra Inc.
Not Provided
Principal Investigator: Don Frei, MD Swedish Medical Center, Denver, CO
Penumbra Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP