Study to Assess the Safety and Effectiveness of the Penumbra System

This study has been completed.
Sponsor:
Information provided by:
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT00334061
First received: June 2, 2006
Last updated: January 9, 2009
Last verified: December 2008
Results First Received: November 20, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke
Intervention: Device: Penumbra System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From June 19, 2006 to June 5, 2007 a total of 856 patients were screened of which 125 patients were enrolled at 24 centers in Europe and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Penumbra System No text entered.

Participant Flow:   Overall Study
    Penumbra System  
STARTED     125 [1]
COMPLETED     125 [2]
NOT COMPLETED     0  
[1] June 2006
[2] November 2007



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Penumbra System No text entered.

Baseline Measures
    Penumbra System  
Number of Participants  
[units: participants]
  125  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     53  
>=65 years     71  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 13.5  
Gender  
[units: participants]
 
Female     61  
Male     64  
Region of Enrollment  
[units: participants]
 
United States     76  
Europe     49  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Revascularization of the Occluded Target Vessel   [ Time Frame: 6-Month Post-Procedure ]

2.  Primary:   Percentage of Participants With Device-related and Procedure-related Serious Adverse Events   [ Time Frame: 6-Month Post-Procedure ]

3.  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   [ Time Frame: Discharge or 30-Days Post-Procedure ]

4.  Secondary:   Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment   [ Time Frame: 90-Day ]
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Measure Type Secondary
Measure Title Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment
Measure Description 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.
Time Frame 90-Day  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Penumbra System No text entered.

Measured Values
    Penumbra System  
Number of Participants Analyzed  
[units: participants]
  125  
Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment  
[units: Percentage¬†of¬†Participants]
  25  

No statistical analysis provided for Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment



5.  Secondary:   Percentage of Participants With All Cause Mortality   [ Time Frame: 90-Days Post-Treatment ]

6.  Secondary:   Percentage of Participants With Symptomatic Hemorrhage   [ Time Frame: 24-Hour Post-Procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information