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

Acute Ischemic Stroke From Large Vessel Occlusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584609
• Other study ID #: CLP 4853
• Secondary ID: CLP 4853
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke From Large Vessel Occlusion
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia
United States	Kaleida Health	Buffalo	New York
United States	Swedish Medical Center	Denver	Colorado
United States	Hartford Hospital	Hartford	Connecticut
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Hoag Hospital	Newport Beach	California
United States	St. Joseph Hospital- Healtheast	Saint Paul	Minnesota
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Device-related Serious Adverse Events		Within 24 hours post-procedure
Primary	Number of Procedure-related Serious Adverse Event		Within 24 hours post-procedure
Secondary	Good Clinical Outcome at 30 Days	Defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1 at Discharge; or a 30-day mRS score of 0-2. The NIHSS is a stroke scale that measures impairment caused by stroke. The Modified Rankin scale (mRS) measures neurological disability or dependence for stroke patients.	30 days post-procedure
Secondary	Number of Participants With 90 Day mRS Score 0-2		at 90 days post-procedure
Secondary	All Cause Mortality		At 90 days post-procedure
Secondary	Number of Symptomatic Intracranial Hemorrhage		Within 24 hours post-procedure
Secondary	Good Neurological Outcome at 90 Days	Defined by an mRS score of 0-2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an improvement of 10 or more points on the NIHSS score	At 90 days post-procedure