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Absolute Pro® MOMENTUM™ (MOMENTUM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444378
First Posted: September 30, 2011
Last Update Posted: June 6, 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: September 26, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Intervention: Device: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems

  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
The first patient was registered in the MOMENTUM trial on November 2011. Enrollment in the trial was closed on November 2013. Based on the February 19, 2015, data extraction, 141 patients were registered in the MOMENTUM trial.at 32 US sites

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® and Pro LL® Peripheral Stent Systems Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.

Participant Flow:   Overall Study
    Absolute Pro® and Pro LL® Peripheral Stent Systems
STARTED   141 [1] 
COMPLETED   124 
NOT COMPLETED   17 
Lost to Follow-up                1 
Withdrawal by Subject                1 
Death                3 
Administrative Closure Of The Study                2 
Missed Visits                10 
[1] A total of 141 patients were enrolled into MOMENTUM



  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.
Intent-to-Treat Population

Reporting Groups
  Description
Absolute Pro® and Pro LL® Peripheral Stent Systems Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.

Baseline Measures
   Absolute Pro® and Pro LL® Peripheral Stent Systems 
Overall Participants Analyzed 
[Units: Participants]
 141 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.3  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      53  37.6% 
Male      88  62.4% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Black or African Heritage   19 
Latino-Hispanic   3 
Native Hawaiian or Other Pacific Islander   0 
White   120 
[1] Subjects who are in multiple race categories are counted in each checked category. The sum of the percentages of all race categories may not equal 100%.
Region of Enrollment 
[Units: Participants]
 
United States   141 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Major Adverse Event (MAE)   [ Time Frame: 30 days ]

2.  Primary:   Freedom From Vessel Patency   [ Time Frame: 0 to 365 days ]

3.  Secondary:   Acute Success : Device Success   [ Time Frame: With in 2 days of index post procedure ]

4.  Secondary:   Acute Success : Clinical Success   [ Time Frame: With in 2 days after index post procedure or at hospital discharge (before 1 month) ]

5.  Secondary:   Acute Success : Technical Success   [ Time Frame: With in 2 days of index post procedure ]

6.  Secondary:   Freedom From Vessel Patency   [ Time Frame: 0 to 30 days ]

7.  Secondary:   Freedom From Vessel Patency   [ Time Frame: 0 to 180 days ]

8.  Secondary:   Ankle Brachial Index (ABI) for the Treated Limb   [ Time Frame: Pre-Procedure ]

9.  Secondary:   Ankle Brachial Index (ABI) for the Treated Limb   [ Time Frame: 1 month ]

10.  Secondary:   Ankle Brachial Index (ABI) for the Treated Limb   [ Time Frame: 6 months ]

11.  Secondary:   Ankle Brachial Index (ABI) for the Treated Limb   [ Time Frame: 12 months ]

12.  Secondary:   Clinically-driven Target Lesion Revascularization (CD-TLR)   [ Time Frame: At 1 month ]

13.  Secondary:   Clinically-driven Target Lesion Revascularization (CD-TLR)   [ Time Frame: At 6 months ]

14.  Secondary:   Clinically-driven Target Lesion Revascularization (CD-TLR)   [ Time Frame: At 1 year ]

15.  Secondary:   Any Target Lesion Revascularization (TLR)   [ Time Frame: At 1 month ]

16.  Secondary:   Any Target Lesion Revascularization (TLR)   [ Time Frame: At 6 months ]

17.  Secondary:   Any Target Lesion Revascularization (TLR)   [ Time Frame: At 1 year ]

18.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: At 1 month ]

19.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: At 6 months ]

20.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: At 1 year ]

21.  Secondary:   Death   [ Time Frame: At 1 month ]

22.  Secondary:   Death   [ Time Frame: At 6 months ]

23.  Secondary:   Death   [ Time Frame: At 1 year ]

24.  Secondary:   Freedom From Stent Patency   [ Time Frame: 0 to 30 days ]

25.  Secondary:   Freedom From Stent Patency   [ Time Frame: 0 to 180 days ]

26.  Secondary:   Freedom From Stent Patency   [ Time Frame: 0 to 365 days ]

27.  Secondary:   Freedom From Stent Patency   [ Time Frame: 0 to 379 days ]

28.  Secondary:   Freedom From Any Ipsilateral Amputation   [ Time Frame: At day 0 (on the day of index procedure) ]

29.  Secondary:   Freedom From Any Ipsilateral Amputation   [ Time Frame: 0 to 30 days ]

30.  Secondary:   Freedom From Any Ipsilateral Amputation   [ Time Frame: 0 to 180 days ]

31.  Secondary:   Freedom From Any Ipsilateral Amputation   [ Time Frame: 0 to 365 days ]

32.  Secondary:   Freedom From Any Ipsilateral Amputation   [ Time Frame: 0 to 379 days ]

33.  Secondary:   Embolic Events in the Treated Limb (as Reported by Site)   [ Time Frame: At 1 month ]

34.  Secondary:   Embolic Events in the Treated Limb (as Reported by Site)   [ Time Frame: At 6 months ]

35.  Secondary:   Embolic Events in the Treated Limb (as Reported by Site)   [ Time Frame: At 1 year ]

36.  Secondary:   Rutherford-Becker Clinical Category for the Treated Limb   [ Time Frame: Pre-procedure ]

37.  Secondary:   Rutherford-Becker Clinical Category for the Treated Limb   [ Time Frame: 1 month ]

38.  Secondary:   Rutherford-Becker Clinical Category for the Treated Limb   [ Time Frame: 6 months ]

39.  Secondary:   Rutherford-Becker Clinical Category for the Treated Limb   [ Time Frame: 12 months ]

40.  Secondary:   Walking Impairment Questionnaire Scores   [ Time Frame: Pre-procedure ]

41.  Secondary:   Walking Impairment Questionnaire Scores   [ Time Frame: 1 month ]

42.  Secondary:   Walking Impairment Questionnaire Scores   [ Time Frame: 6 months ]

43.  Secondary:   Walking Impairment Questionnaire Scores   [ Time Frame: 12 months ]

44.  Secondary:   Maximum Walking Distance   [ Time Frame: Pre-procedure ]

45.  Secondary:   Maximum Walking Distance   [ Time Frame: 1 month ]

46.  Secondary:   Maximum Walking Distance   [ Time Frame: 6 months ]

47.  Secondary:   Maximum Walking Distance   [ Time Frame: 12 months ]

48.  Secondary:   Stent Integrity by X-ray   [ Time Frame: 12 months ]

49.  Secondary:   Toe Brachial Index (TBI)   [ Time Frame: At 1 month ]

50.  Secondary:   Toe Brachial Index (TBI)   [ Time Frame: At 6 months ]

51.  Secondary:   Toe Brachial Index (TBI)   [ Time Frame: At 1 year ]

52.  Secondary:   Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)   [ Time Frame: 1 month ]

53.  Secondary:   Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)   [ Time Frame: 12 months ]

54.  Secondary:   Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)   [ Time Frame: 1 month ]

55.  Secondary:   Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)   [ Time Frame: 12 months ]

56.  Secondary:   Acute Stent Thrombosis   [ Time Frame: 0 - 24 Hours Post Study Procedure ]

57.  Secondary:   Sub-Acute Stent Thrombosis   [ Time Frame: > 24 Hours – 30 Days Post Study Procedure ]

58.  Secondary:   Stent Occlusion   [ Time Frame: > 30 Days Post Study Procedure ]

59.  Secondary:   In-Segment Percent Diameter Stenosis (%DS)   [ Time Frame: Pre-Procedure ]

60.  Secondary:   In-Segment Percent Diameter Stenosis (%DS)   [ Time Frame: Post-Procedure (≥ 1 day) ]

61.  Secondary:   In-Stent Percent Diameter Stenosis (%DS)   [ Time Frame: Post-Procedure (≥ 1 day) ]

62.  Secondary:   Freedom From Ipsilateral Major Amputation   [ Time Frame: At day 0 (on the day of index procedure) ]

63.  Secondary:   Freedom From Ipsilateral Major Amputation   [ Time Frame: 0 to 30 days ]

64.  Secondary:   Freedom From Ipsilateral Major Amputation   [ Time Frame: 0 to 180 days ]

65.  Secondary:   Freedom From Ipsilateral Major Amputation   [ Time Frame: 0 to 365 days ]

66.  Secondary:   Freedom From Ipsilateral Major Amputation   [ Time Frame: 0 to 379 days ]

67.  Secondary:   Quality of Life Measures : Physical Functioning (PF)   [ Time Frame: 1 month ]

68.  Secondary:   Quality of Life Measures : Physical Functioning (PF)   [ Time Frame: 6 months ]

69.  Secondary:   Quality of Life Measures : Physical Functioning (PF)   [ Time Frame: 1 year ]

70.  Secondary:   Quality of Life Measures : Role Physical (RP)   [ Time Frame: 1 month ]

71.  Secondary:   Quality of Life Measures : Role Physical (RP)   [ Time Frame: 6 months ]

72.  Secondary:   Quality of Life Measures : Role Physical (RP)   [ Time Frame: 1 year ]

73.  Secondary:   Quality of Life Measures : Bodily Pain (BP)   [ Time Frame: 1 month ]

74.  Secondary:   Quality of Life Measures : Bodily Pain (BP)   [ Time Frame: 6 months ]

75.  Secondary:   Quality of Life Measures : Bodily Pain (BP)   [ Time Frame: 1 year ]

76.  Secondary:   Quality of Life Measures : General Health (GH)   [ Time Frame: 1 month ]

77.  Secondary:   Quality of Life Measures : General Health (GH)   [ Time Frame: 6 months ]

78.  Secondary:   Quality of Life Measures : General Health (GH)   [ Time Frame: 1 year ]

79.  Secondary:   Quality of Life Measures : Vitality (VT)   [ Time Frame: 1 month ]

80.  Secondary:   Quality of Life Measures : Vitality (VT)   [ Time Frame: 6 months ]

81.  Secondary:   Quality of Life Measures : Vitality (VT)   [ Time Frame: 1 year ]

82.  Secondary:   Quality of Life Measures : Social Functioning (SF)   [ Time Frame: 1 month ]

83.  Secondary:   Quality of Life Measures : Social Functioning (SF)   [ Time Frame: 6 months ]

84.  Secondary:   Quality of Life Measures : Social Functioning (SF)   [ Time Frame: 1 year ]

85.  Secondary:   Quality of Life Measures : Role Emotional (RE)   [ Time Frame: 1 month ]

86.  Secondary:   Quality of Life Measures : Role Emotional (RE)   [ Time Frame: 6 months ]

87.  Secondary:   Quality of Life Measures : Role Emotional (RE)   [ Time Frame: 1 year ]

88.  Secondary:   Quality of Life Measures : Mental Health (MH)   [ Time Frame: 1 month ]

89.  Secondary:   Quality of Life Measures : Mental Health (MH)   [ Time Frame: 6 months ]

90.  Secondary:   Quality of Life Measures : Mental Health (MH)   [ Time Frame: 1 year ]

91.  Secondary:   Quality of Life Measures : Physical Component Summary (PCS)   [ Time Frame: 1 month ]

92.  Secondary:   Quality of Life Measures : Physical Component Summary (PCS)   [ Time Frame: 6 months ]

93.  Secondary:   Quality of Life Measures : Physical Component Summary (PCS)   [ Time Frame: 1 year ]

94.  Secondary:   Quality of Life Measures : Mental Component Summary (MCS)   [ Time Frame: 1 month ]

95.  Secondary:   Quality of Life Measures : Mental Component Summary (MCS)   [ Time Frame: 6 months ]

96.  Secondary:   Quality of Life Measures : Mental Component Summary (MCS)   [ Time Frame: 1 year ]

97.  Secondary:   Vascular Quality of Life (VascuQol) Total Scores   [ Time Frame: 1 month ]

98.  Secondary:   Vascular Quality of Life (VascuQol) Total Scores   [ Time Frame: 6 months ]

99.  Secondary:   Vascular Quality of Life (VascuQol) Total Scores   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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: Robert McGreevy
Organization: Abbott Vascular
phone: 408-845-3932
e-mail: Robert.mcgreevy@abbott.com



Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01444378     History of Changes
Other Study ID Numbers: 10-110
First Submitted: September 21, 2011
First Posted: September 30, 2011
Results First Submitted: September 26, 2016
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017



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