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The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00814970
First received: December 23, 2008
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: April 22, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral Vascular Disease
Intervention: Device: Complete SE Vascular 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
Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.

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
Complete Self-expanding (SE) Vascular Stent System

Device: Complete Self-expanding (SE) Vascular Stent System >

> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.


Participant Flow:   Overall Study
    Complete Self-expanding (SE) Vascular Stent System  
STARTED     196  
COMPLETED     146  
NOT COMPLETED     50  



  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
Complete SE Vascular Stent System

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.


Baseline Measures
    Complete SE Vascular Stent System  
Number of Participants  
[units: participants]
  196  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     74  
>=65 years     122  
Age  
[units: years]
Mean ± Standard Deviation
  68.7  ± 10.5  
Gender  
[units: participants]
 
Female     72  
Male     124  
Region of Enrollment  
[units: participants]
 
United States     133  
Germany     48  
Belgium     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Major Adverse Event (MAE) Rate   [ Time Frame: 12 Months ]

2.  Primary:   Primary Patency Rate   [ Time Frame: 12 Months ]

3.  Secondary:   Major Adverse Event (MAE) Rate   [ Time Frame: 30 days ]

4.  Secondary:   Major Adverse Event (MAE) Rate   [ Time Frame: 6 Months ]

5.  Secondary:   Device Success   [ Time Frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). ]

6.  Secondary:   Lesion Success   [ Time Frame: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient). ]

7.  Secondary:   Procedure Success   [ Time Frame: At time of deployment to time of hospital discharge ]

8.  Secondary:   Assisted Primary Patency   [ Time Frame: 12 months ]

9.  Secondary:   Secondary Patency Rate   [ Time Frame: 12 Months ]

10.  Secondary:   Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category   [ Time Frame: 12 months ]

11.  Secondary:   Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15   [ Time Frame: 12 Months ]

12.  Secondary:   Change in Quality of Life - Decrease in Rutherford Class >= 1 Category   [ Time Frame: 30 Days ]

13.  Secondary:   Percentage of Participants Free From Strut Fractures   [ Time Frame: 12 Months ]

14.  Secondary:   Clinically-driven Target Lesion Revascularization (TLR) Rate   [ Time Frame: 12 Months ]

15.  Secondary:   Major Adverse Event (MAE) Rate   [ Time Frame: 24 Months ]

16.  Secondary:   Percentage of Participants Free From Strut Fractures   [ Time Frame: 24 Months ]

17.  Secondary:   Major Adverse Event (MAE) Rate   [ Time Frame: 36 Months ]

18.  Secondary:   Percentage of Participants Free From Strut Fractures   [ Time Frame: 36 Months ]


  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
No text entered.


  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 less than or equal to 60 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: Beaux S. Alexander - Clinical Research Director, Peripheral Clinical
Organization: Medtronic Endovascular Therapies
phone: (707) 591-7291
e-mail: beaux.s.alexander@medtronic.com


No publications provided by Medtronic Endovascular

Publications automatically indexed to this study:

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00814970     History of Changes
Other Study ID Numbers: IP105, IDE G080143
Study First Received: December 23, 2008
Results First Received: April 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration