Study to Assess the Safety and Effectiveness of the Penumbra System
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|ClinicalTrials.gov Identifier: NCT00334061|
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : January 12, 2009
Last Update Posted : September 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Penumbra System||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||November 2007|
- 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.
- Percentage of Participants With Device-related and Procedure-related Serious Adverse Events [ Time Frame: 3-Month Post-Procedure ]
- 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.
- 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.
- Percentage of Participants With All Cause Mortality [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334061
|United States, Missouri|
|Saint Luke's Hospital|
|Kansas City, Missouri, United States, 64111|