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IN.PACT Global Clinical Study

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.
 
ClinicalTrials.gov Identifier: NCT01609296
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : January 28, 2019
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: IN.PACT Admiral™ Drug Eluting Balloon Not Applicable

Detailed Description:

Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.

The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1535 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
Study Start Date : May 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : January 17, 2020

Arm Intervention/treatment
Experimental: IN.PACT Admiral DEB
The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.
Device: IN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.




Primary Outcome Measures :
  1. Clinical Cohort ITT - Primary Effectiveness Endpoint [ Time Frame: 12 months ]
    Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  2. Clinical Cohort ITT - Primary Safety Endpoint [ Time Frame: 12 months ]
    A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.

  3. Imaging Cohort ITT - Primary Effectiveness Endpoint [ Time Frame: 12 months ]

    Primary Patency within 12 months post-index procedure, which is defined as:

    • Freedom from clinically-driven TLR and
    • Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.

      • Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab.

  4. 150mm DEB ITT Cohort - Primary Effectiveness Endpoint [ Time Frame: 12 months ]

    Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as:

    • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.



Secondary Outcome Measures :
  1. Clinical Cohort ITT - MAEs [ Time Frame: 12 months ]
    MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.

  2. Clinical Cohort ITT - TLR [ Time Frame: 12 months ]
    Any Target lesion revascularisation

  3. Clinical Cohort ITT - TVR [ Time Frame: 12 months. ]
    Any Target vessel revascularisation

  4. Clinical Cohort ITT - Device Success [ Time Frame: Index-procedure ]
    Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)

  5. Clinical Cohort ITT - Clinical Success [ Time Frame: prior to discharge ]
    Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge

  6. Clinical Cohort ITT - MAEs [ Time Frame: 60 months ]
    MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

  7. Clinical Cohort ITT - Clinically-driven TLR [ Time Frame: 60 months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  8. Clinical Cohort ITT - TVR [ Time Frame: 60 months ]
  9. Clinical Cohort ITT - TLR [ Time Frame: 60 months ]
  10. Clinical Cohort ITT - Time to First Clinically-driven TLR (Days) [ Time Frame: 60 months ]
  11. Clinical Cohort ITT - MAEs [ Time Frame: 30 days ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.

  12. Clinical Cohort ITT - MAEs [ Time Frame: 6 Months ]
    MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site

  13. Clinical Cohort ITT - MAEs [ Time Frame: 24 Months ]
    MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

  14. Clinical Cohort ITT - MAEs [ Time Frame: 36 Months ]
    MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

  15. Clinical Cohort ITT - MAEs [ Time Frame: 48 Months ]
    MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.

  16. Clinical Cohort ITT - Clinically-driven TLR [ Time Frame: 30 days ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  17. Clinical Cohort ITT - Clinically-driven TLR [ Time Frame: 6 Months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  18. Clinical Cohort ITT - Clinically-driven TLR [ Time Frame: 24 Months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  19. Clinical Cohort ITT - Clinically-driven TLR [ Time Frame: 36 Months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  20. Clinical Cohort ITT - Clinically-driven TLR [ Time Frame: 48 Months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  21. Clinical Cohort ITT - TLR [ Time Frame: 6 Months ]
    Any Target lesion revascularisation

  22. Clinical Cohort ITT - TLR [ Time Frame: 24 Months ]
    Any Target lesion revascularisation

  23. Clinical Cohort ITT - TLR [ Time Frame: 36 Months ]
    Any Target lesion revascularisation

  24. Clinical Cohort ITT - TLR [ Time Frame: 48 Months ]
    Any Target lesion revascularisation

  25. Clinical Cohort ITT - TVR [ Time Frame: 24 Months ]
    Any Target lesion revascularisation

  26. Clinical Cohort ITT - TVR [ Time Frame: 36 Months ]
    Any Target lesion revascularisation

  27. Clinical Cohort ITT - TVR [ Time Frame: 48 Months ]
    Any Target lesion revascularisation

  28. Clinical Cohort ITT - TVR [ Time Frame: 6 Months ]
    Any Target lesion revascularisation

  29. Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure. [ Time Frame: 60 months ]
    All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months

  30. Clinical Cohort ITT - Primary Sustained Clinical Improvement [ Time Frame: 6 Months ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects

  31. Clinical Cohort ITT - Primary Sustained Clinical Improvement [ Time Frame: 12 Months ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects

  32. Clinical Cohort ITT - Primary Sustained Clinical Improvement [ Time Frame: 24 Months ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects

  33. Clinical Cohort ITT - Primary Sustained Clinical Improvement [ Time Frame: 36 Months ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects

  34. Clinical Cohort ITT - Secondary Sustained Clinical Improvement [ Time Frame: 6 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  35. Clinical Cohort ITT - Secondary Sustained Clinical Improvement [ Time Frame: 12 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  36. Clinical Cohort ITT - Secondary Sustained Clinical Improvement [ Time Frame: 24 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  37. Clinical Cohort ITT - Secondary Sustained Clinical Improvement [ Time Frame: 36 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  38. Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure [ Time Frame: Post procedure ]
    Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9

  39. Clinical Cohort ITT - Sustained Hemodynamic Improvement [ Time Frame: 6 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  40. Clinical Cohort ITT - Sustained Hemodynamic Improvement [ Time Frame: 12 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  41. Clinical Cohort ITT - Sustained Hemodynamic Improvement [ Time Frame: 24 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  42. Clinical Cohort ITT - Sustained Hemodynamic Improvement [ Time Frame: 36 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  43. Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 6 Months ]
  44. Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 12 Months ]
  45. Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 24 Months ]
  46. Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 36 Months ]
  47. Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 6 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  48. Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 12 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  49. Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 24 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  50. Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 36 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  51. Clinical Cohort ITT - Procedural Success [ Time Frame: at procedure ]
    Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate

  52. Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion [ Time Frame: at 12 months, or at the time of re-intervention ]
  53. Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion [ Time Frame: At 12 months, or at the time of re-intervention ]
  54. 150mm DEB ITT Cohort - MAEs [ Time Frame: 30 days ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.

  55. 150mm DEB ITT Cohort - MAEs [ Time Frame: 6 months ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.

  56. 150mm DEB ITT Cohort - MAEs [ Time Frame: 12 months ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.

  57. 150mm DEB ITT Cohort - MAEs [ Time Frame: 24 months ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.

  58. 150mm DEB ITT Cohort - MAEs [ Time Frame: 36 months ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.

  59. 150mm DEB ITT Cohort - MAEs [ Time Frame: 48 months ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.

  60. 150mm DEB ITT Cohort - MAEs [ Time Frame: 60 months ]
    Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.

  61. 150mm DEB ITT Cohort - Clinically-driven TLR [ Time Frame: 30 days ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  62. 150mm DEB ITT Cohort - Clinically-driven TLR [ Time Frame: 6 months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  63. 150mm DEB ITT Cohort - Clinically-driven TLR [ Time Frame: 24 months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  64. 150mm DEB ITT Cohort - Clinically-driven TLR [ Time Frame: 36 months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  65. 150mm DEB ITT Cohort - Clinically-driven TLR [ Time Frame: 48 months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  66. 150mm DEB ITT Cohort - Clinically-driven TLR [ Time Frame: 60 months ]
    Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  67. 150mm DEB ITT Cohort - TLR [ Time Frame: 6 Months ]
    Any Target lesion revascularisation

  68. 150mm DEB ITT Cohort - TLR [ Time Frame: 12 Months ]
    Any Target lesion revascularisation

  69. 150mm DEB ITT Cohort - TLR [ Time Frame: 24 Months ]
    Any Target lesion revascularisation

  70. 150mm DEB ITT Cohort - TLR [ Time Frame: 36 Months ]
    Any Target lesion revascularisation

  71. 150mm DEB ITT Cohort - TLR [ Time Frame: 48 Months ]
    Any Target lesion revascularisation

  72. 150mm DEB ITT Cohort - TLR [ Time Frame: 60 Months ]
    Any Target lesion revascularisation

  73. 150mm DEB ITT Cohort - TVR [ Time Frame: 6 Months ]
    Any Target lesion revascularisation

  74. 150mm DEB ITT Cohort - TVR [ Time Frame: 12 Months ]
    Any Target lesion revascularisation

  75. 150mm DEB ITT Cohort - TVR [ Time Frame: 24 Months ]
    Any Target lesion revascularisation

  76. 150mm DEB ITT Cohort - TVR [ Time Frame: 36 Months ]
    Any Target lesion revascularisation

  77. 150mm DEB ITT Cohort - TVR [ Time Frame: 48 Months ]
    Any Target lesion revascularisation

  78. 150mm DEB ITT Cohort - TVR [ Time Frame: 60 Months ]
    Any Target lesion revascularisation

  79. 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days) [ Time Frame: 60 months ]
  80. 150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure. [ Time Frame: 60 months ]
    All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months

  81. 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement [ Time Frame: 6 months. ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  82. 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement [ Time Frame: 12 months. ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  83. 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement [ Time Frame: 24 months ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  84. 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement [ Time Frame: 36 months ]
    Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  85. 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement [ Time Frame: 6 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  86. 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement [ Time Frame: 12 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  87. 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement [ Time Frame: 24 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  88. 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement [ Time Frame: 36 Months ]
    Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  89. 150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure [ Time Frame: Post procedure ]
    Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9

  90. 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement [ Time Frame: 6 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  91. 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement [ Time Frame: 12 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  92. 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement [ Time Frame: 24 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  93. 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement [ Time Frame: 36 Months ]
    Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.

  94. 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 6 Months ]
  95. 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 12 Months ]
  96. 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 24 Months ]
  97. 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) [ Time Frame: 36 Months ]
  98. 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 6 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  99. 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 12 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  100. 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 24 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  101. 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) [ Time Frame: 36 Months ]
    The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.

  102. 150mm DEB ITT Cohort - Device Success [ Time Frame: Index-procedure ]
    Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)

  103. 150mm DEB ITT Cohort - Procedural Success [ Time Frame: at procedure ]
    Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate

  104. 150mm DEB ITT Cohort - Clinical Success [ Time Frame: prior to discharge ]
    Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge

  105. Clinical Cohort ITT - All-cause Mortality [ Time Frame: 30 days ]
  106. Clinical Cohort ITT - All-cause Mortality [ Time Frame: 6 Months ]
  107. Clinical Cohort ITT - All-cause Mortality [ Time Frame: 12 Months ]
  108. Clinical Cohort ITT - All-cause Mortality [ Time Frame: 24 Months ]
  109. Clinical Cohort ITT - All-cause Mortality [ Time Frame: 36 Months ]
  110. Clinical Cohort ITT - All-cause Mortality [ Time Frame: 48 Months ]
  111. Clinical Cohort ITT - All-cause Mortality [ Time Frame: 60 Months ]

    The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow:

    1. Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation
    2. Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation
    3. Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit.
    4. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)

  112. Clinical Cohort ITT - Clinically-driven TVR [ Time Frame: 30 days ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  113. Clinical Cohort ITT - Clinically-driven TVR [ Time Frame: 6 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  114. Clinical Cohort ITT - Clinically-driven TVR [ Time Frame: 12 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  115. Clinical Clinical Cohort ITT - Clinically-driven TVR [ Time Frame: 24 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  116. Clinical Cohort ITT - Clinically-driven TVR [ Time Frame: 36 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  117. Clinical Cohort ITT - Clinically-driven TVR [ Time Frame: 48 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  118. Clinical Cohort ITT - Clinically-driven TVR [ Time Frame: 60 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  119. Clinical Cohort ITT - Major Target Limb Amputation [ Time Frame: 30 days ]
  120. Clinical Cohort ITT - Major Target Limb Amputation [ Time Frame: 6 Months ]
  121. Clinical Cohort ITT - Major Target Limb Amputation [ Time Frame: 12 Months ]
  122. Clinical Cohort ITT - Major Target Limb Amputation [ Time Frame: 24 Months ]
  123. Clinical Cohort ITT - Major Target Limb Amputation [ Time Frame: 36 Months ]
  124. Clinical Cohort ITT - Major Target Limb Amputation [ Time Frame: 48 Months ]
  125. Clinical Cohort ITT - Major Target Limb Amputation [ Time Frame: 60 Months ]
  126. 150mm DEB ITT Cohort - All-cause Mortality [ Time Frame: 30 days ]
  127. 150mm DEB ITT Cohort - All-cause Mortality [ Time Frame: 6 Months ]
  128. 150mm DEB ITT Cohort - All-cause Mortality [ Time Frame: 12 Months ]
  129. 150mm DEB ITT Cohort - All-cause Mortality [ Time Frame: 24 Months ]
  130. 150mm DEB ITT Cohort - All-cause Mortality [ Time Frame: 36 Months ]
  131. 150mm DEB ITT Cohort - All-cause Mortality [ Time Frame: 48 Months ]
  132. 150mm DEB ITT Cohort - All-cause Mortality [ Time Frame: 60 Months ]
  133. 150mm DEB ITT Cohort - Clinically-driven TVR [ Time Frame: 30 days ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  134. 150mm DEB ITT Cohort - Clinically-driven TVR [ Time Frame: 6 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  135. 150mm DEB ITT Cohort - Clinically-driven TVR [ Time Frame: 12 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  136. 150mm DEB ITT Cohort - Clinically-driven TVR [ Time Frame: 24 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  137. 150mm DEB ITT Cohort - Clinically-driven TVR [ Time Frame: 36 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  138. 150mm DEB ITT Cohort - Clinically-driven TVR [ Time Frame: 48 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  139. 150mm DEB ITT Cohort - Clinically-driven TVR [ Time Frame: 60 Months ]
    Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

  140. 150mm DEB ITT Cohort - Major Target Limb Amputation [ Time Frame: 30 days ]
  141. 150mm DEB ITT Cohort - Major Target Limb Amputation [ Time Frame: 6 Months ]
  142. 150mm DEB ITT Cohort - Major Target Limb Amputation [ Time Frame: 12 Months ]
  143. 150mm DEB ITT Cohort - Major Target Limb Amputation [ Time Frame: 24 Months ]
  144. 150mm DEB ITT Cohort - Major Target Limb Amputation [ Time Frame: 36 Months ]
  145. 150mm DEB ITT Cohort - Major Target Limb Amputation [ Time Frame: 48 Months ]
  146. 150mm DEB ITT Cohort - Major Target Limb Amputation [ Time Frame: 60 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General inclusion Criteria:

  • Age ≥ 18 years or minimum age as required by local regulations.
  • Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
  • Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.

General exclusion Criteria:

  • High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
  • Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
  • Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609296


Locations
Show Show 65 study locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Gunnar Tepe, MD Klinikum Rosenheim
Principal Investigator: Gary Ansel, MD MidOhio Cardiology and Vascular Consultants
Principal Investigator: Marc Bosiers, MD AZ Sint Blasius
Principal Investigator: Do-Dai Do, MD Swiss Cardiovascular Center, Inselspital
Principal Investigator: Peter Gaines, MD Sheffield Vascular Institute
Principal Investigator: Alvaro Razuk, MD Faculdade de Ciências Médicas da Santa Casa de Sao Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01609296    
Other Study ID Numbers: 10048613
First Posted: May 31, 2012    Key Record Dates
Results First Posted: January 28, 2019
Last Update Posted: March 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Endovascular:
Peripheral Arterial Disease
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Superficial Femoral Artery
Popliteal Femoral Artery
Atherosclerosis
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Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases