Penumbra System in Stroke - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Stroke

Intervention / Treatment

Device: Penumbra System

Detailed Description

Purpose:

The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will be enrolled in the study.

Study Type

Interventional

Enrollment (Actual)

125

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical signs consistent with acute ischemic stroke
18 to 79 years of age
Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 8
TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
Signed informed consent
Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.

Exclusion Criteria:

Evidence of rapidly improving neurological signs of stroke at time of enrollment
NIHSS > 30 or coma
Females who are pregnant
Vessel tortuosity too difficult to allow endovascular access
Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) > 3.0
Partial thromboplastin time (PTT) greater than 2 times the lab normal
Admission platelets < 30,000
Pre-existing neurological or psychiatric disease that could confound the study results
Known severe allergy to contrast media
Uncontrolled hypertension
Computed tomography (CT) evidence of significant mass effect with a midline shift
CT reveals evidence of large hypodensity region > 1/3 of the middle cerebral artery territory
CT reveals evidence of intracranial hemorrhage
CT reveals significant mass effect with midline shift
Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
Angiographic evidence of preexisting arterial injury
Life expectancy of less than 90 days
Participation in another clinical investigation that could confound the evaluation of the study device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Revascularization of the Occluded Target Vessel Time Frame: 3-Month Post-Procedure	Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.	3-Month Post-Procedure
Percentage of Participants With Device-related and Procedure-related Serious Adverse Events Time Frame: 3-Month Post-Procedure		3-Month Post-Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment Time Frame: Discharge or 30-Days Post-Procedure	NIHSS is a 42 point scale to describe the neurological status of the patients: 0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.	Discharge or 30-Days Post-Procedure
Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment Time Frame: 90-Day	The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.	90-Day
Percentage of Participants With All Cause Mortality Time Frame: 90-Days Post-Treatment		90-Days Post-Treatment
Percentage of Participants With Symptomatic Hemorrhage Time Frame: 24-Hour Post-Procedure	All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.	24-Hour Post-Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penumbra Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria