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

NCT01584609 | Completed Results DMC

• 1 other identifier: CLP 4853
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 8

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.

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

Keywords

ischemic stroke; large vessel occlusion; mechanical thrombectomy; revascularization; Penumbra System; Separator 3D

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Good Clinical Outcome at 30 Days

  30 days post-procedure

• 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

  At 90 days post-procedure

Study Arms (2)

Penumbra System with Separator 3D

EXPERIMENTAL

Device: Penumbra System with Separator 3D

Penumbra System alone

ACTIVE COMPARATOR

Device: Penumbra System alone

Interventions

Penumbra System with Separator 3D DEVICE

The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.

Penumbra System with Separator 3D

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.

Penumbra System alone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (8)

Hoag Hospital

Newport Beach, California, 92658, United States

Location

Swedish Medical Center

Denver, Colorado, 80112, United States

Location

Hartford Hospital

Hartford, Connecticut, 6106, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

St. Joseph Hospital- Healtheast

Saint Paul, Minnesota, 55102, United States

Location

Kaleida Health

Buffalo, New York, 14209, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794-8122, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 29296999 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Michaella Corso
• Organization: Penumbra, Inc.

mcorso@penumbrainc.com

(510) 748-3200

Study Officials

• Don Frei, MD

  Swedish Medical Center, Denver, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 13, 2018
• Results First Posted: September 13, 2018

Record last verified: 2018-08

Locations

US (8)