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Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery. (MOBILITY AP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00844532
First received: February 12, 2009
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
Results First Received: March 30, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral Vascular Disease
Intervention: Device: Absolute Pro™ Peripheral 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
Trial population is comprised of male and female subjects with moderate to severe iliac artery atherosclerotic occlusive disease. Recruitment dates: March 23, 2009 through May 17, 2010

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
Absolute Pro™ Peripheral Self-Expanding Stent System The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.

Participant Flow:   Overall Study
    Absolute Pro™ Peripheral Self-Expanding Stent System  
STARTED     151  
COMPLETED     143  
NOT COMPLETED     8  
Withdrawal by Subject                 2  
No data available                 2  
Death                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Absolute Pro™ Peripheral Self-Expanding Stent System The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.

Baseline Measures
    Absolute Pro™ Peripheral Self-Expanding Stent System  
Number of Participants  
[units: participants]
 		  151  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     85  
>=65 years     66  
Age  
[units: years]
Mean ± Standard Deviation 		  62.8  ± 9.3  
Gender  
[units: participants]
 		 
Female     53  
Male     98  
Region of Enrollment  
[units: participants]
 		 
United States     151  



  Outcome Measures
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1.  Primary:   Major Adverse Event (MAE) Rate   [ Time Frame: 9 months ]
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2.  Secondary:   Device Success   [ Time Frame: acute: from beginning of index procedure to end of index proceedure. ]
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3.  Secondary:   Technical Success   [ Time Frame: acute: from beginning of index procedure to end of index proceedure. ]
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4.  Secondary:   Procedure Success   [ Time Frame: Beginning of index procedure to 2 days post-index proceedure or discharge, whichever is sooner ]
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5.  Secondary:   Rutherford Becker Clinical Category for the Treated Limb(s)   [ Time Frame: Pre-Procedure ]
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6.  Secondary:   Rutherford Becker Clinical Category for the Treated Limb(s)   [ Time Frame: 1 month ]
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7.  Secondary:   Rutherford Becker Clinical Category for the Treated Limb(s)   [ Time Frame: 9 months ]
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8.  Secondary:   Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)   [ Time Frame: Between baseline and 9 months ]
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9.  Secondary:   Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: Pre-proceedure ]
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10.  Secondary:   Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: Post-proceedure ]
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11.  Secondary:   Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: 1 month ]
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12.  Secondary:   Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: 9 months ]
  Show Outcome Measure 12

13.  Secondary:   Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: Post-proceedure ]
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14.  Secondary:   Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: 1 month ]
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15.  Secondary:   Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: 9 months ]
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16.  Secondary:   Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)   [ Time Frame: 1 month and 9 months ]
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17.  Secondary:   Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)   [ Time Frame: 1 month and 9 months ]
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18.  Secondary:   Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)   [ Time Frame: 1 month and 9 months ]
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19.  Secondary:   Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)   [ Time Frame: 1 month and 9 months ]
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20.  Secondary:   Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)   [ Time Frame: 1 month and 9 months ]
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21.  Secondary:   Primary Stent Patency   [ Time Frame: 1 month ]
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22.  Secondary:   Primary Stent Patency   [ Time Frame: 9 months ]
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23.  Secondary:   Kaplan-Meier Estimate of Freedom From Death (All Cause)   [ Time Frame: 1 month and 9 months ]
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24.  Secondary:   Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)   [ Time Frame: 1 month and 9 months ]
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25.  Secondary:   Stent Thrombosis   [ Time Frame: 1 month ]
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26.  Secondary:   Kaplan-Meier Estimate of Freedom From Embolic Events   [ Time Frame: 1 month and 9 months ]
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27.  Secondary:   Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)   [ Time Frame: 1 month and 9 months ]
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28.  Secondary:   Restenosis   [ Time Frame: 9 months ]
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29.  Secondary:   Walking Impairment Questionaire Scores   [ Time Frame: Pre-procedure ]
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30.  Secondary:   Walking Impairment Questionaire Scores   [ Time Frame: 1 month ]
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31.  Secondary:   Walking Impairment Questionaire Scores   [ Time Frame: 9 months ]
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32.  Secondary:   Changes in Quality of Life Measures: Physical Component Summary   [ Time Frame: Baseline and 1 month ]
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33.  Secondary:   Changes in Quality of Life Measures: Physical Component Summary   [ Time Frame: Baseline and 9 months ]
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34.  Secondary:   Changes in Quality of Life Measures: Mental Component Summary   [ Time Frame: Baseline and 1 month ]
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35.  Secondary:   Changes in Quality of Life Measures: Mental Component Summary   [ Time Frame: Baseline and 9 months ]
  Show Outcome Measure 35

36.  Secondary:   Rutherford Becker Clinical Category for the Treated Limb(s)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

37.  Secondary:   Rutherford Becker Clinical Category for the Treated Limb(s)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

38.  Secondary:   Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

39.  Secondary:   Thigh Brachial Index (TBI) for the Treated Limb(s)   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

40.  Secondary:   Primary Stent Patency   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

41.  Secondary:   Primary Stent Patency   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

42.  Secondary:   Restenosis   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

43.  Secondary:   Restenosis   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

44.  Secondary:   Walking Impairment Questionaire Scores   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

45.  Secondary:   Walking Impairment Questionaire Scores   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Ellen Travis
Organization: Abbott Vascular
phone: 408-845-3000
e-mail: Ellen.Travis@av.abbott.com


No publications provided


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00844532     History of Changes
Other Study ID Numbers: 08-107 Absolute Pro Arm (AP), 08-107 OE
Study First Received: February 12, 2009
Results First Received: March 30, 2012
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration