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Data Registry Following Patients Using Supera Stent in the Femoral Arteries (STRONG)

This study has been terminated.
(Slow enrollment,increased loss to follow-ups and general lack of interest.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154751
First Posted: July 1, 2010
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Vascular
Results First Submitted: October 25, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Peripheral Artery Disease
Femoropopliteal Artery Stenosis
Peripheral Vascular Disease
Intervention: Device: SUPERA Interwoven self-expanding nitinol stent

  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
This study planned to recruit up to 200 patients across 5-10 sites in the European Union. However, during the course of the study, intake was halted at 109 patients and the registry was terminated early because of slow enrollment, increased loss to follow-ups, and general lack of interest.

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
Device SUPERA Stent

SUPERA Interwoven Self-Expanding Nitinol Stent System

SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area


Participant Flow for 4 periods

Period 1:   6-month Follow-up
    Device SUPERA Stent
STARTED   109 
COMPLETED   98 
NOT COMPLETED   11 

Period 2:   1-year Follow-up
    Device SUPERA Stent
STARTED   98 
COMPLETED   93 
NOT COMPLETED   5 

Period 3:   2-year Follow-up
    Device SUPERA Stent
STARTED   93 
COMPLETED   83 
NOT COMPLETED   10 

Period 4:   3-year Follow-up
    Device SUPERA Stent
STARTED   83 
COMPLETED   34 
NOT COMPLETED   49 



  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
Device SUPERA Stent

SUPERA Interwoven Self-Expanding Nitinol Stent System

SUPERA Interwoven self-expanding nitinol stent: Insertion of stent at stenotic area


Baseline Measures
   Device SUPERA Stent 
Overall Participants Analyzed 
[Units: Participants]
 109 
Age 
[Units: Years]
Mean (Standard Deviation)
 71  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      36  33.0% 
Male      73  67.0% 
Region of Enrollment 
[Units: Participants]
 
Germany   109 
Lesion length [1] 
[Units: Centimeters]
Mean (Standard Deviation)
 
Superficial femoral (n=86)   16.40  (28.93) 
Popliteal (n=22)   7.77  (5.00) 
Femoropopliteal conjunction (n=3)   18.67  (2.31) 
[1] Lesion length is site reported
Percent diameter stenosis [1] 
[Units: Percentage diameter stenosis]
Mean (Standard Deviation)
 
Superficial femoral (n=87)   93.07  (8.78) 
Popliteal (n=23)   93.83  (7.91) 
Femoropopliteal conjunction (n=3)   96.67  (5.77) 
[1] Percent diameter stenosis is site reported.
Occlusion [1] 
[Units: Participants]
 50 
[1] Core laboratory reported


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Six-minute Walking Distance   [ Time Frame: At baseline ]

2.  Primary:   Six-minute Walking Distance   [ Time Frame: 30 days ]

3.  Primary:   Six-minute Walking Distance   [ Time Frame: 6 months ]

4.  Primary:   Six-minute Walking Distance   [ Time Frame: 1 Year ]

5.  Secondary:   Number of Participants Experiencing Peri-procedural and Post-procedural Complications   [ Time Frame: 30 days ]

6.  Secondary:   Number of Peri-procedural and Post-procedural Complications   [ Time Frame: 30 days ]

7.  Secondary:   Rutherford-Becker Clinical Category   [ Time Frame: 30 days ]

8.  Secondary:   Restenosis by Duplex Ultrasound   [ Time Frame: 6 months ]

9.  Secondary:   Restenosis by Duplex Ultrasound   [ Time Frame: 1 Year ]

10.  Secondary:   Target Lesion Revascularization   [ Time Frame: 6 months ]

11.  Secondary:   Target Lesion Revascularization   [ Time Frame: 1 Year ]

12.  Secondary:   Stent Fracture   [ Time Frame: 1 Year ]

13.  Secondary:   Stent Fracture   [ Time Frame: 1 to 2 years ]

14.  Secondary:   Stent Fracture   [ Time Frame: 1 to 3 Years ]

15.  Secondary:   Target Limb Ankle Brachial Index (at Rest)   [ Time Frame: At baseline ]

16.  Secondary:   Target Limb Ankle Brachial Index (at Rest)   [ Time Frame: 30 days ]

17.  Secondary:   Target Limb Ankle Brachial Index (at Rest)   [ Time Frame: 6 months ]

18.  Secondary:   Target Limb Ankle Brachial Index (at Rest)   [ Time Frame: 1 Year ]

19.  Secondary:   Target Limb Ankle Brachial Index (at Rest)   [ Time Frame: 2 Years ]

20.  Secondary:   Six-minute Walking Distance   [ Time Frame: 2 Years ]


  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 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: Margo Zaugg
Organization: Abbott Vascular
phone: 408-845-0576
e-mail: margo.zaugg@av.abbott.com



Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01154751     History of Changes
Other Study ID Numbers: IDEV Technologies, Inc.
First Submitted: June 29, 2010
First Posted: July 1, 2010
Results First Submitted: October 25, 2016
Results First Posted: August 17, 2017
Last Update Posted: September 19, 2017