Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00530712
First received: September 14, 2007
Last updated: July 28, 2014
Last verified: July 2014
Results First Received: July 28, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Peripheral Vascular Diseases
Claudication
Intervention: Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent 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
No text entered.

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
EverFlex™ Peripheral Self-Expanding Stent System Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System

Participant Flow for 4 periods

Period 1:   Enrollment
    EverFlex™ Peripheral Self-Expanding Stent System  
STARTED     287 [1]
COMPLETED     287 [2]
NOT COMPLETED     0  
[1] Total Enrolled Subjects
[2] Subjects Available at Discharge

Period 2:   30 Day Follow-up Visit
    EverFlex™ Peripheral Self-Expanding Stent System  
STARTED     287 [1]
COMPLETED     280 [2]
NOT COMPLETED     7  
Withdrawal by Subject                 2  
Missed Visit                 5  
[1] Subjects Expected for 30-Day Visit
[2] Subjects that Completed 30-Day Follow-up Visit

Period 3:   6 Month Follow-up Visit
    EverFlex™ Peripheral Self-Expanding Stent System  
STARTED     287 [1]
COMPLETED     275 [2]
NOT COMPLETED     12  
Withdrawal by Subject                 4  
Missed Visit                 3  
Lost to Follow-up                 3  
Death                 2  
[1] Subjects Expected for 6-Month Visit
[2] Subjects that Completed 6-Month Follow-up Visit

Period 4:   12 Month Follow-up Visit
    EverFlex™ Peripheral Self-Expanding Stent System  
STARTED     287 [1]
COMPLETED     263 [2]
NOT COMPLETED     24  
Withdrawal by Subject                 5  
Missed Visit                 3  
Lost to Follow-up                 7  
Death                 9  
[1] Subjects Expected for 12 Month Visit
[2] Subjects that Completed 12-Month Follow-up Visit



  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.
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Reporting Groups
  Description
EverFlex™ Peripheral Self-Expanding Stent System Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System

Baseline Measures
    EverFlex™ Peripheral Self-Expanding Stent System  
Number of Participants  
[units: participants]
  287  
Age  
[units: years]
Mean ± Standard Deviation
  67.7  ± 10.7  
Gender  
[units: participants]
 
Female     97  
Male     190  
Region of Enrollment  
[units: participants]
 
United States     244  
Europe     43  



  Outcome Measures
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1.  Primary:   Primary Patency   [ Time Frame: 1 Year ]

2.  Primary:   Major Adverse Events   [ Time Frame: 30 Days ]

3.  Secondary:   Single-Stent Primary Patency   [ Time Frame: 1 Year ]

4.  Secondary:   Single-Stent Major Adverse Events   [ Time Frame: 30 Days ]

5.  Secondary:   Major Adverse Events   [ Time Frame: 1 Year ]

6.  Secondary:   Stent Fracture Rate   [ Time Frame: 1, 2 and 3 Years ]

7.  Secondary:   Improvement in Rutherford Clinical Category   [ Time Frame: 1 Year ]

8.  Secondary:   Increase in Ankle-Brachial Index   [ Time Frame: 1 Year ]

9.  Secondary:   Assisted Primary Patency   [ Time Frame: 1 Year ]

10.  Secondary:   Secondary Patency   [ Time Frame: 1 Year ]

11.  Secondary:   Absolute Claudication Distance Improvement   [ Time Frame: 1 Year ]

12.  Secondary:   Duplex Ultrasound ≤ 2.4 Primary Patency   [ Time Frame: 1 Year ]

13.  Secondary:   Decline in Rutherford Clinical Category   [ Time Frame: 30 Days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

14.  Secondary:   Walking Improvement   [ Time Frame: 1 Year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
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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.


Results Point of Contact:  
Name/Title: Director Clincal Affairs
Organization: Covidien
e-mail: Julie.Messer@covidien.com


Publications of Results:

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00530712     History of Changes
Other Study ID Numbers: P-2424
Study First Received: September 14, 2007
Results First Received: July 28, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration