IN.PACT Global Clinical Study

• 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: Medtronic Endovascular
• Information provided by (Responsible Party): Medtronic Endovascular

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Argentina

Fundación Favaloro

Buenos Aires, Argentina

Clinica La Sagrada Familia

Bueos Aires, Argentina

Australia

Royal Prince Alfred Hospital

Sydney, Australia, NSW 2050

Austria

Medizinische Universität Graz

Graz, Austria, 8036

Landesklinikum Thermenregion Mödling

Mödling, Austria, 2340

Belgium

Onze-Lieve-Vrouwziekenuis

Aalst, Belgium, 9300

Imelda Ziekenhuis

Bonheiden, Belgium, 2820

AZ St. Blasius

Dendermonde, Belgium, 9200

Universitair Ziekenhuis Antwerpen

Edegem, Belgium, 2650

Ziekenhuis Oost Limburg - Campus St.-Jan

Genk, Belgium, 3600

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

Regionaal Ziekenhuis Heilig Hart

Tienen, Belgium, 3300

Canada

Centre hospitalier universitaire Sherbrooke (CHUS)

Sherbrooke, Canada

Toronto General Hospital

Toronto, Canada

Colombia

Clinica Santa Maria

Medellin, Colombia

Clinica Medilaser Neiva

Neiva, Colombia

Czechia

Faculty Hospital Hradec Kralove

Hradec Kralove, Czechia, 50005

Egypt

As-Salam International Hospital

Cairo, Egypt

Egypt Air Hospital

Cairo, Egypt

Finland

Helsingin Seudun Yliopistollinen Keskussairaala

Helsinki, Finland

France

Group Hospitalier Pellegrin - CHU

Bordeaux Cedex, France, 33076

Les Hospitaux Universitaires de Strasbourg

Strasbourg, France, 67000

Germany

Herzzentrum Bad Krozingen

Bad Krozingen, Germany, 79189

Augusta-Krankenhaus

Duesseldorf, Germany

Augusta Krankenhaus

Düsseldorf, Germany, 40472

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Universitatsklinikum Leipzig AoR

Leipzig, Germany, 04103

Park-Krankenhaus Leipzig

Leipzig, Germany, 04289

St. Franziskus Hospital GmbH

Münster, Germany, 48145

RoMed Klinikum Rosenheim

Rosenheim, Germany, 83022

Universitätsklinikum Tübingen

Tübingen, Germany, 72076

Greece

University Hospital of Patras

Patra, Greece, TK26504

Hungary

Semmelweis University

Budapest, Hungary, 1122

Bacs Kiskun Megyei Korhaz

Kecskemét, Hungary, 6000

Israel

Carmel Medical Centre

Haifa, Israel, 34362

Rabin Medical Center - Beilison Hospital

Petach Tikva, Israel, 49100

Italy

Policlinico Vittorio Emanuele

Catania, Italy, 95123

Maria Eleonora Hospital

Palermo, Italy, 90135

Policlinico Gemelli

Rome, Italy, 00168

Korea, Republic of

Severence Hospital

Seoul, Korea, Republic of, 120-752

Samsung Medical Center

Seoul, Korea, Republic of, 135-710

Asan Medical Center

Seoul, Korea, Republic of, 138-736

Korea University Guro Hospital

Seoul, Korea, Republic of, 152-703

Ajou University Hospital

Suwon, Korea, Republic of, 443-380

Lithuania

Kaunas Mecial University Clinic

Kaunas, Lithuania, 50009

Netherlands

Jeroen Bosch Ziekenhuis

's Hertogenbosch, Netherlands, 5223GZ

Rijnstate Ziekenhuis

Arnhem, Netherlands, 6800TA

Catharina Ziekenhuis

Eindhoven, Netherlands, 5623EJ

Sint Antonius Hospital

Nieuwegein, Netherlands, 3430EM

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands, 3584CX

Poland

Euromedic Medical Center

Katowice, Poland, 40-519

Samodzielny Publiczny Szpital Kliniczny Nr 2

Szczecin, Poland, 70-111

Portugal

Hospital Santa Marta

Lisbon, Portugal, 1169-024

Russian Federation

City Clinical Hospital named after M.E. Zhadkevich

Moscow, Russian Federation, 121374

Singapore

Changi General Hospital

Singapore, Singapore, 529889

Slovakia

Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)

Banská Bystrica, Slovakia, 97401

Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)

Bratislava, Slovakia, 83348

Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)

Kosice, Slovakia, 04011

Slovenia

University Medical Centre Maribor

Maribor, Slovenia, 2000

Sweden

Karolinska Universitetssjukhuset

Solna, Sweden, 17176

Switzerland

Inselspital - Universitätsspial Bern

Bern, Switzerland, 3010

Hopital Cantonal HFR

Fribourg, Switzerland, 1708

Kantonspital Luzern

Luzern, Switzerland, 6000

United Kingdom

Manchester Royal Infirmary

Manchester, United Kingdom, M139WL

Northern General Hospital

Sheffield, United Kingdom, S57AU

Sponsors and Collaborators

Medtronic Endovascular

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.

Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.

Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.

Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.

Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.

Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.

Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.

Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:

Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available.

Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available.

Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.

Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.

Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT01609296
• Other Study ID Numbers: 10048613
• First Posted: May 31, 2012
• 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; Drug coated balloon; Superficial Femoral Artery; Popliteal Femoral Artery; Atherosclerosis; Drug eluting balloon

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases