Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01609296




Registration number
NCT01609296
Ethics application status
Date submitted
24/05/2012
Date registered
31/05/2012
Date last updated
25/03/2021

Titles & IDs
Public title
IN.PACT Global Clinical Study
Scientific 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.
Secondary ID [1] 0 0
10048613
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - IN.PACT Admiral™ Drug Eluting Balloon

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.


Treatment: Devices: IN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Cohort ITT - Primary Effectiveness Endpoint
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Clinical Cohort ITT - Primary Safety Endpoint
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Imaging Cohort ITT - Primary Effectiveness Endpoint
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Timepoint [4] 0 0
12 months
Secondary outcome [1] 0 0
Clinical Cohort ITT - MAEs
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Clinical Cohort ITT - TLR
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Clinical Cohort ITT - TVR
Timepoint [3] 0 0
12 months.
Secondary outcome [4] 0 0
Clinical Cohort ITT - Device Success
Timepoint [4] 0 0
Index-procedure
Secondary outcome [5] 0 0
Clinical Cohort ITT - Clinical Success
Timepoint [5] 0 0
prior to discharge
Secondary outcome [6] 0 0
Clinical Cohort ITT - MAEs
Timepoint [6] 0 0
60 months
Secondary outcome [7] 0 0
Clinical Cohort ITT - Clinically-driven TLR
Timepoint [7] 0 0
60 months
Secondary outcome [8] 0 0
Clinical Cohort ITT - TVR
Timepoint [8] 0 0
60 months
Secondary outcome [9] 0 0
Clinical Cohort ITT - TLR
Timepoint [9] 0 0
60 months
Secondary outcome [10] 0 0
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Timepoint [10] 0 0
60 months
Secondary outcome [11] 0 0
Clinical Cohort ITT - MAEs
Timepoint [11] 0 0
30 days
Secondary outcome [12] 0 0
Clinical Cohort ITT - MAEs
Timepoint [12] 0 0
6 Months
Secondary outcome [13] 0 0
Clinical Cohort ITT - MAEs
Timepoint [13] 0 0
24 Months
Secondary outcome [14] 0 0
Clinical Cohort ITT - MAEs
Timepoint [14] 0 0
36 Months
Secondary outcome [15] 0 0
Clinical Cohort ITT - MAEs
Timepoint [15] 0 0
48 Months
Secondary outcome [16] 0 0
Clinical Cohort ITT - Clinically-driven TLR
Timepoint [16] 0 0
30 days
Secondary outcome [17] 0 0
Clinical Cohort ITT - Clinically-driven TLR
Timepoint [17] 0 0
6 Months
Secondary outcome [18] 0 0
Clinical Cohort ITT - Clinically-driven TLR
Timepoint [18] 0 0
24 Months
Secondary outcome [19] 0 0
Clinical Cohort ITT - Clinically-driven TLR
Timepoint [19] 0 0
36 Months
Secondary outcome [20] 0 0
Clinical Cohort ITT - Clinically-driven TLR
Timepoint [20] 0 0
48 Months
Secondary outcome [21] 0 0
Clinical Cohort ITT - TLR
Timepoint [21] 0 0
6 Months
Secondary outcome [22] 0 0
Clinical Cohort ITT - TLR
Timepoint [22] 0 0
24 Months
Secondary outcome [23] 0 0
Clinical Cohort ITT - TLR
Timepoint [23] 0 0
36 Months
Secondary outcome [24] 0 0
Clinical Cohort ITT - TLR
Timepoint [24] 0 0
48 Months
Secondary outcome [25] 0 0
Clinical Cohort ITT - TVR
Timepoint [25] 0 0
24 Months
Secondary outcome [26] 0 0
Clinical Cohort ITT - TVR
Timepoint [26] 0 0
36 Months
Secondary outcome [27] 0 0
Clinical Cohort ITT - TVR
Timepoint [27] 0 0
48 Months
Secondary outcome [28] 0 0
Clinical Cohort ITT - TVR
Timepoint [28] 0 0
6 Months
Secondary outcome [29] 0 0
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
Timepoint [29] 0 0
60 months
Secondary outcome [30] 0 0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Timepoint [30] 0 0
6 Months
Secondary outcome [31] 0 0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Timepoint [31] 0 0
12 Months
Secondary outcome [32] 0 0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Timepoint [32] 0 0
24 Months
Secondary outcome [33] 0 0
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Timepoint [33] 0 0
36 Months
Secondary outcome [34] 0 0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Timepoint [34] 0 0
6 Months
Secondary outcome [35] 0 0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Timepoint [35] 0 0
12 Months
Secondary outcome [36] 0 0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Timepoint [36] 0 0
24 Months
Secondary outcome [37] 0 0
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Timepoint [37] 0 0
36 Months
Secondary outcome [38] 0 0
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Timepoint [38] 0 0
Post procedure
Secondary outcome [39] 0 0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Timepoint [39] 0 0
6 Months
Secondary outcome [40] 0 0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Timepoint [40] 0 0
12 Months
Secondary outcome [41] 0 0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Timepoint [41] 0 0
24 Months
Secondary outcome [42] 0 0
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Timepoint [42] 0 0
36 Months
Secondary outcome [43] 0 0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [43] 0 0
6 Months
Secondary outcome [44] 0 0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [44] 0 0
12 Months
Secondary outcome [45] 0 0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [45] 0 0
24 Months
Secondary outcome [46] 0 0
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [46] 0 0
36 Months
Secondary outcome [47] 0 0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [47] 0 0
6 Months
Secondary outcome [48] 0 0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [48] 0 0
12 Months
Secondary outcome [49] 0 0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [49] 0 0
24 Months
Secondary outcome [50] 0 0
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [50] 0 0
36 Months
Secondary outcome [51] 0 0
Clinical Cohort ITT - Procedural Success
Timepoint [51] 0 0
at procedure
Secondary outcome [52] 0 0
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
Timepoint [52] 0 0
at 12 months, or at the time of re-intervention
Secondary outcome [53] 0 0
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
Timepoint [53] 0 0
At 12 months, or at the time of re-intervention
Secondary outcome [54] 0 0
150mm DEB ITT Cohort - MAEs
Timepoint [54] 0 0
30 days
Secondary outcome [55] 0 0
150mm DEB ITT Cohort - MAEs
Timepoint [55] 0 0
6 months
Secondary outcome [56] 0 0
150mm DEB ITT Cohort - MAEs
Timepoint [56] 0 0
12 months
Secondary outcome [57] 0 0
150mm DEB ITT Cohort - MAEs
Timepoint [57] 0 0
24 months
Secondary outcome [58] 0 0
150mm DEB ITT Cohort - MAEs
Timepoint [58] 0 0
36 months
Secondary outcome [59] 0 0
150mm DEB ITT Cohort - MAEs
Timepoint [59] 0 0
48 months
Secondary outcome [60] 0 0
150mm DEB ITT Cohort - MAEs
Timepoint [60] 0 0
60 months
Secondary outcome [61] 0 0
150mm DEB ITT Cohort - Clinically-driven TLR
Timepoint [61] 0 0
30 days
Secondary outcome [62] 0 0
150mm DEB ITT Cohort - Clinically-driven TLR
Timepoint [62] 0 0
6 months
Secondary outcome [63] 0 0
150mm DEB ITT Cohort - Clinically-driven TLR
Timepoint [63] 0 0
24 months
Secondary outcome [64] 0 0
150mm DEB ITT Cohort - Clinically-driven TLR
Timepoint [64] 0 0
36 months
Secondary outcome [65] 0 0
150mm DEB ITT Cohort - Clinically-driven TLR
Timepoint [65] 0 0
48 months
Secondary outcome [66] 0 0
150mm DEB ITT Cohort - Clinically-driven TLR
Timepoint [66] 0 0
60 months
Secondary outcome [67] 0 0
150mm DEB ITT Cohort - TLR
Timepoint [67] 0 0
6 Months
Secondary outcome [68] 0 0
150mm DEB ITT Cohort - TLR
Timepoint [68] 0 0
12 Months
Secondary outcome [69] 0 0
150mm DEB ITT Cohort - TLR
Timepoint [69] 0 0
24 Months
Secondary outcome [70] 0 0
150mm DEB ITT Cohort - TLR
Timepoint [70] 0 0
36 Months
Secondary outcome [71] 0 0
150mm DEB ITT Cohort - TLR
Timepoint [71] 0 0
48 Months
Secondary outcome [72] 0 0
150mm DEB ITT Cohort - TLR
Timepoint [72] 0 0
60 Months
Secondary outcome [73] 0 0
150mm DEB ITT Cohort - TVR
Timepoint [73] 0 0
6 Months
Secondary outcome [74] 0 0
150mm DEB ITT Cohort - TVR
Timepoint [74] 0 0
12 Months
Secondary outcome [75] 0 0
150mm DEB ITT Cohort - TVR
Timepoint [75] 0 0
24 Months
Secondary outcome [76] 0 0
150mm DEB ITT Cohort - TVR
Timepoint [76] 0 0
36 Months
Secondary outcome [77] 0 0
150mm DEB ITT Cohort - TVR
Timepoint [77] 0 0
48 Months
Secondary outcome [78] 0 0
150mm DEB ITT Cohort - TVR
Timepoint [78] 0 0
60 Months
Secondary outcome [79] 0 0
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
Timepoint [79] 0 0
60 months
Secondary outcome [80] 0 0
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
Timepoint [80] 0 0
60 months
Secondary outcome [81] 0 0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Timepoint [81] 0 0
6 months.
Secondary outcome [82] 0 0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Timepoint [82] 0 0
12 months.
Secondary outcome [83] 0 0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Timepoint [83] 0 0
24 months
Secondary outcome [84] 0 0
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Timepoint [84] 0 0
36 months
Secondary outcome [85] 0 0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Timepoint [85] 0 0
6 Months
Secondary outcome [86] 0 0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Timepoint [86] 0 0
12 Months
Secondary outcome [87] 0 0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Timepoint [87] 0 0
24 Months
Secondary outcome [88] 0 0
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Timepoint [88] 0 0
36 Months
Secondary outcome [89] 0 0
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
Timepoint [89] 0 0
Post procedure
Secondary outcome [90] 0 0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Timepoint [90] 0 0
6 Months
Secondary outcome [91] 0 0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Timepoint [91] 0 0
12 Months
Secondary outcome [92] 0 0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Timepoint [92] 0 0
24 Months
Secondary outcome [93] 0 0
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Timepoint [93] 0 0
36 Months
Secondary outcome [94] 0 0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [94] 0 0
6 Months
Secondary outcome [95] 0 0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [95] 0 0
12 Months
Secondary outcome [96] 0 0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [96] 0 0
24 Months
Secondary outcome [97] 0 0
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Timepoint [97] 0 0
36 Months
Secondary outcome [98] 0 0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [98] 0 0
6 Months
Secondary outcome [99] 0 0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [99] 0 0
12 Months
Secondary outcome [100] 0 0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [100] 0 0
24 Months
Secondary outcome [101] 0 0
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Timepoint [101] 0 0
36 Months
Secondary outcome [102] 0 0
150mm DEB ITT Cohort - Device Success
Timepoint [102] 0 0
Index-procedure
Secondary outcome [103] 0 0
150mm DEB ITT Cohort - Procedural Success
Timepoint [103] 0 0
at procedure
Secondary outcome [104] 0 0
150mm DEB ITT Cohort - Clinical Success
Timepoint [104] 0 0
prior to discharge
Secondary outcome [105] 0 0
Clinical Cohort ITT - All-cause Mortality
Timepoint [105] 0 0
30 days
Secondary outcome [106] 0 0
Clinical Cohort ITT - All-cause Mortality
Timepoint [106] 0 0
6 Months
Secondary outcome [107] 0 0
Clinical Cohort ITT - All-cause Mortality
Timepoint [107] 0 0
12 Months
Secondary outcome [108] 0 0
Clinical Cohort ITT - All-cause Mortality
Timepoint [108] 0 0
24 Months
Secondary outcome [109] 0 0
Clinical Cohort ITT - All-cause Mortality
Timepoint [109] 0 0
36 Months
Secondary outcome [110] 0 0
Clinical Cohort ITT - All-cause Mortality
Timepoint [110] 0 0
48 Months
Secondary outcome [111] 0 0
Clinical Cohort ITT - All-cause Mortality
Timepoint [111] 0 0
60 Months
Secondary outcome [112] 0 0
Clinical Cohort ITT - Clinically-driven TVR
Timepoint [112] 0 0
30 days
Secondary outcome [113] 0 0
Clinical Cohort ITT - Clinically-driven TVR
Timepoint [113] 0 0
6 Months
Secondary outcome [114] 0 0
Clinical Cohort ITT - Clinically-driven TVR
Timepoint [114] 0 0
12 Months
Secondary outcome [115] 0 0
Clinical Clinical Cohort ITT - Clinically-driven TVR
Timepoint [115] 0 0
24 Months
Secondary outcome [116] 0 0
Clinical Cohort ITT - Clinically-driven TVR
Timepoint [116] 0 0
36 Months
Secondary outcome [117] 0 0
Clinical Cohort ITT - Clinically-driven TVR
Timepoint [117] 0 0
48 Months
Secondary outcome [118] 0 0
Clinical Cohort ITT - Clinically-driven TVR
Timepoint [118] 0 0
60 Months
Secondary outcome [119] 0 0
Clinical Cohort ITT - Major Target Limb Amputation
Timepoint [119] 0 0
30 days
Secondary outcome [120] 0 0
Clinical Cohort ITT - Major Target Limb Amputation
Timepoint [120] 0 0
6 Months
Secondary outcome [121] 0 0
Clinical Cohort ITT - Major Target Limb Amputation
Timepoint [121] 0 0
12 Months
Secondary outcome [122] 0 0
Clinical Cohort ITT - Major Target Limb Amputation
Timepoint [122] 0 0
24 Months
Secondary outcome [123] 0 0
Clinical Cohort ITT - Major Target Limb Amputation
Timepoint [123] 0 0
36 Months
Secondary outcome [124] 0 0
Clinical Cohort ITT - Major Target Limb Amputation
Timepoint [124] 0 0
48 Months
Secondary outcome [125] 0 0
Clinical Cohort ITT - Major Target Limb Amputation
Timepoint [125] 0 0
60 Months
Secondary outcome [126] 0 0
150mm DEB ITT Cohort - All-cause Mortality
Timepoint [126] 0 0
30 days
Secondary outcome [127] 0 0
150mm DEB ITT Cohort - All-cause Mortality
Timepoint [127] 0 0
6 Months
Secondary outcome [128] 0 0
150mm DEB ITT Cohort - All-cause Mortality
Timepoint [128] 0 0
12 Months
Secondary outcome [129] 0 0
150mm DEB ITT Cohort - All-cause Mortality
Timepoint [129] 0 0
24 Months
Secondary outcome [130] 0 0
150mm DEB ITT Cohort - All-cause Mortality
Timepoint [130] 0 0
36 Months
Secondary outcome [131] 0 0
150mm DEB ITT Cohort - All-cause Mortality
Timepoint [131] 0 0
48 Months
Secondary outcome [132] 0 0
150mm DEB ITT Cohort - All-cause Mortality
Timepoint [132] 0 0
60 Months
Secondary outcome [133] 0 0
150mm DEB ITT Cohort - Clinically-driven TVR
Timepoint [133] 0 0
30 days
Secondary outcome [134] 0 0
150mm DEB ITT Cohort - Clinically-driven TVR
Timepoint [134] 0 0
6 Months
Secondary outcome [135] 0 0
150mm DEB ITT Cohort - Clinically-driven TVR
Timepoint [135] 0 0
12 Months
Secondary outcome [136] 0 0
150mm DEB ITT Cohort - Clinically-driven TVR
Timepoint [136] 0 0
24 Months
Secondary outcome [137] 0 0
150mm DEB ITT Cohort - Clinically-driven TVR
Timepoint [137] 0 0
36 Months
Secondary outcome [138] 0 0
150mm DEB ITT Cohort - Clinically-driven TVR
Timepoint [138] 0 0
48 Months
Secondary outcome [139] 0 0
150mm DEB ITT Cohort - Clinically-driven TVR
Timepoint [139] 0 0
60 Months
Secondary outcome [140] 0 0
150mm DEB ITT Cohort - Major Target Limb Amputation
Timepoint [140] 0 0
30 days
Secondary outcome [141] 0 0
150mm DEB ITT Cohort - Major Target Limb Amputation
Timepoint [141] 0 0
6 Months
Secondary outcome [142] 0 0
150mm DEB ITT Cohort - Major Target Limb Amputation
Timepoint [142] 0 0
12 Months
Secondary outcome [143] 0 0
150mm DEB ITT Cohort - Major Target Limb Amputation
Timepoint [143] 0 0
24 Months
Secondary outcome [144] 0 0
150mm DEB ITT Cohort - Major Target Limb Amputation
Timepoint [144] 0 0
36 Months
Secondary outcome [145] 0 0
150mm DEB ITT Cohort - Major Target Limb Amputation
Timepoint [145] 0 0
48 Months
Secondary outcome [146] 0 0
150mm DEB ITT Cohort - Major Target Limb Amputation
Timepoint [146] 0 0
60 Months

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/01/2020
Sample size
Target
Accrual to date
Final
1535
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Bueos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Mödling
Country [5] 0 0
Belgium
State/province [5] 0 0
Aalst
Country [6] 0 0
Belgium
State/province [6] 0 0
Bonheiden
Country [7] 0 0
Belgium
State/province [7] 0 0
Dendermonde
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Genk
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Tienen
Country [12] 0 0
Canada
State/province [12] 0 0
Sherbrooke
Country [13] 0 0
Canada
State/province [13] 0 0
Toronto
Country [14] 0 0
Colombia
State/province [14] 0 0
Medellin
Country [15] 0 0
Colombia
State/province [15] 0 0
Neiva
Country [16] 0 0
Czechia
State/province [16] 0 0
Hradec Kralove
Country [17] 0 0
Egypt
State/province [17] 0 0
Cairo
Country [18] 0 0
Finland
State/province [18] 0 0
Helsinki
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux Cedex
Country [20] 0 0
France
State/province [20] 0 0
Strasbourg
Country [21] 0 0
Germany
State/province [21] 0 0
Bad Krozingen
Country [22] 0 0
Germany
State/province [22] 0 0
Duesseldorf
Country [23] 0 0
Germany
State/province [23] 0 0
Düsseldorf
Country [24] 0 0
Germany
State/province [24] 0 0
Heidelberg
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Germany
State/province [26] 0 0
Münster
Country [27] 0 0
Germany
State/province [27] 0 0
Rosenheim
Country [28] 0 0
Germany
State/province [28] 0 0
Tübingen
Country [29] 0 0
Greece
State/province [29] 0 0
Patra
Country [30] 0 0
Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Hungary
State/province [31] 0 0
Kecskemét
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
State/province [33] 0 0
Petach Tikva
Country [34] 0 0
Italy
State/province [34] 0 0
Catania
Country [35] 0 0
Italy
State/province [35] 0 0
Palermo
Country [36] 0 0
Italy
State/province [36] 0 0
Rome
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Suwon
Country [39] 0 0
Lithuania
State/province [39] 0 0
Kaunas
Country [40] 0 0
Netherlands
State/province [40] 0 0
's Hertogenbosch
Country [41] 0 0
Netherlands
State/province [41] 0 0
Arnhem
Country [42] 0 0
Netherlands
State/province [42] 0 0
Eindhoven
Country [43] 0 0
Netherlands
State/province [43] 0 0
Nieuwegein
Country [44] 0 0
Netherlands
State/province [44] 0 0
Utrecht
Country [45] 0 0
Poland
State/province [45] 0 0
Katowice
Country [46] 0 0
Poland
State/province [46] 0 0
Szczecin
Country [47] 0 0
Portugal
State/province [47] 0 0
Lisbon
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Moscow
Country [49] 0 0
Singapore
State/province [49] 0 0
Singapore
Country [50] 0 0
Slovakia
State/province [50] 0 0
Banská Bystrica
Country [51] 0 0
Slovakia
State/province [51] 0 0
Bratislava
Country [52] 0 0
Slovakia
State/province [52] 0 0
Kosice
Country [53] 0 0
Slovenia
State/province [53] 0 0
Maribor
Country [54] 0 0
Sweden
State/province [54] 0 0
Solna
Country [55] 0 0
Switzerland
State/province [55] 0 0
Bern
Country [56] 0 0
Switzerland
State/province [56] 0 0
Fribourg
Country [57] 0 0
Switzerland
State/province [57] 0 0
Luzern
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Manchester
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Endovascular
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01609296
Trial related presentations / publications
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 May 28;73(20):2643-2645. doi: 10.1016/j.jacc.2019.02.029.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Gunnar Tepe, MD
Address 0 0
Klinikum Rosenheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01609296