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 ]

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

Measure Type Secondary
Measure Title Percentage of Participants With All Cause Mortality
Measure Description No text entered.
Time Frame 90-Days Post-Treatment  
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 All Cause Mortality  
[units: Percentage¬†of¬†Participants]
  32.8  

No statistical analysis provided for Percentage of Participants With All Cause Mortality



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


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Siu Po Sit, PhD Study Coordinator
Organization: Penumbra Inc
phone: 510 748 3200 ext 221
e-mail: siupo.sit@penumbrainc.com


No publications provided


ClinicalTrials.gov Identifier: NCT00334061     History of Changes
Other Study ID Numbers: CLP 0676
Study First Received: June 2, 2006
Results First Received: November 20, 2008
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices