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

NCT ID: NCT01584609

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Penumbra System with Separator 3D

Group Type: EXPERIMENTAL

Penumbra System with Separator 3D

Intervention Type: DEVICE

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

Penumbra System alone

Group Type: ACTIVE_COMPARATOR

Penumbra System alone

Intervention Type: 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.

Interventions

Penumbra System with Separator 3D

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

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Don Frei, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center, Denver, CO

Locations

Hoag Hospital

Newport Beach, California, United States

Swedish Medical Center

Denver, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Grady Health System

Atlanta, Georgia, United States

St. Joseph Hospital- Healtheast

Saint Paul, Minnesota, United States

Kaleida Health

Buffalo, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29296999 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLP 4853

Identifier Type: OTHER

Identifier Source: secondary_id

CLP 4853

Identifier Type: -

Identifier Source: org_study_id