Study to Assess the Safety and Effectiveness of the Penumbra System

Stroke Clinical Trial

Official title:

Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334061
• Other study ID #: CLP 0676
• Status: Completed
• Phase: Phase 2
• Start date: June 2006
• Est. completion date: November 2007

Study information

• Verified date: September 2019
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical evaluation is a prospective, single-arm, multi-center trial.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Penumbra System

Locations

Country	Name	City	State
United States	Saint Luke's Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Revascularization of the Occluded Target Vessel	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
Primary	Percentage of Participants With Device-related and Procedure-related Serious Adverse Events		3-Month Post-Procedure
Secondary	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	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
Secondary	Percentage of Participants With a Modified Rankin Scale (mRS) Score of = 2 at 90 Days Post Treatment	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
Secondary	Percentage of Participants With All Cause Mortality		90-Days Post-Treatment
Secondary	Percentage of Participants With Symptomatic Hemorrhage	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

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