Trial Outcomes & Findings for IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA (NCT NCT02963649)
NCT ID: NCT02963649
Last Updated: 2025-07-08
Results Overview
Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
9 Months
Results posted on
2025-07-08
Participant Flow
Participant milestones
| Measure |
Drug Coated Balloon IN.PACT 014
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
Participants who receive standard PTA treatment
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
27
|
|
Overall Study
COMPLETED
|
11
|
16
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Drug Coated Balloon IN.PACT 014
n=25 Lesions
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=30 Lesions
Participants who receive standard PTA treatment
|
Total
n=55 Lesions
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 Years
STANDARD_DEVIATION 7.4 • n=23 Participants
|
69.6 Years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
71.20 Years
STANDARD_DEVIATION 8.60 • n=50 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=23 Participants
|
7 Participants
n=27 Participants
|
11 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=23 Participants
|
20 Participants
n=27 Participants
|
39 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Obesity, BMI >=30kg/m2
|
5 Participants
n=22 Participants • Denominator is subjects with available data.
|
7 Participants
n=26 Participants • Denominator is subjects with available data.
|
12 Participants
n=48 Participants • Denominator is subjects with available data.
|
|
Diabetes Mellitus
|
17 Participants
n=23 Participants
|
26 Participants
n=27 Participants
|
43 Participants
n=50 Participants
|
|
Diabetes Mellitus Insulin-dependent
|
9 Participants
n=23 Participants
|
20 Participants
n=27 Participants
|
29 Participants
n=50 Participants
|
|
Hypertension
|
19 Participants
n=23 Participants
|
21 Participants
n=27 Participants
|
40 Participants
n=50 Participants
|
|
Hyperlipideamia
|
16 Participants
n=22 Participants • Denominator is subjects with available data.
|
20 Participants
n=25 Participants • Denominator is subjects with available data.
|
36 Participants
n=47 Participants • Denominator is subjects with available data.
|
|
Current smoker
|
4 Participants
n=23 Participants • Denominator is subjects with available data.
|
3 Participants
n=26 Participants • Denominator is subjects with available data.
|
7 Participants
n=49 Participants • Denominator is subjects with available data.
|
|
End-stage renal disease
|
0 Participants
n=23 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
|
Cerebrovascular disease
|
6 Participants
n=23 Participants • Denominator is subjects with available data.
|
3 Participants
n=26 Participants • Denominator is subjects with available data.
|
9 Participants
n=49 Participants • Denominator is subjects with available data.
|
|
Congestive heart failure
|
2 Participants
n=23 Participants • Denominator is subjects with available data.
|
5 Participants
n=26 Participants • Denominator is subjects with available data.
|
7 Participants
n=49 Participants • Denominator is subjects with available data.
|
|
Ischaemic heart disease
|
10 Participants
n=23 Participants • Denominator is subjects with available data.
|
9 Participants
n=26 Participants • Denominator is subjects with available data.
|
19 Participants
n=49 Participants • Denominator is subjects with available data.
|
|
Bilateral PAD
|
12 Participants
n=22 Participants • Denominator is subjects with available data.
|
14 Participants
n=22 Participants • Denominator is subjects with available data.
|
26 Participants
n=44 Participants • Denominator is subjects with available data.
|
|
Previous peripheral revascularisation of target limb
|
7 Participants
n=23 Participants
|
9 Participants
n=27 Participants
|
16 Participants
n=50 Participants
|
|
Previous minor target limb amputation
|
3 Participants
n=23 Participants
|
11 Participants
n=27 Participants
|
14 Participants
n=50 Participants
|
|
Rutherford category 4
|
3 Participants
n=23 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=50 Participants
|
|
Rutherford category 5
|
20 Participants
n=23 Participants
|
24 Participants
n=27 Participants
|
44 Participants
n=50 Participants
|
|
Rutherford category 6
|
0 Participants
n=23 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=50 Participants
|
|
Target lesion location - Popliteal P3 segment
|
2 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
1 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
3 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Target lesion location - Tibio-peroneal trunk
|
4 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
4 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
8 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Target lesion location - Anterior tibial
|
17 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
15 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
32 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Target lesion location - posterior tibial
|
6 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
12 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
18 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Target lesion location - Peroneal
|
1 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
2 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
3 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Inflow in the target vessel (<30% residual stenosis)
|
18 Participants
n=20 Participants • Participant-based assessment. Denominator is subjects with available data.
|
21 Participants
n=24 Participants • Participant-based assessment. Denominator is subjects with available data.
|
39 Participants
n=44 Participants • Participant-based assessment. Denominator is subjects with available data.
|
|
Lesion type - De novo
|
20 Lesions
n=25 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
26 Lesions
n=30 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
46 Lesions
n=55 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
|
Lesion type - Restenotic (non-stented)
|
5 Lesions
n=25 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
4 Lesions
n=30 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
9 Lesions
n=55 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
|
Lesion length
|
215.41 mm
STANDARD_DEVIATION 83.81 • n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
218.19 mm
STANDARD_DEVIATION 80.43 • n=28 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
216.91 mm
STANDARD_DEVIATION 81.20 • n=52 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
Occluded lesion (site reported data)
|
25 Lesions
n=25 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
30 Lesions
n=30 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
55 Lesions
n=55 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50.
|
|
Total occluded lesion length, mm
|
159.00 mm
STANDARD_DEVIATION 84.66 • n=21 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
136.43 mm
STANDARD_DEVIATION 72.82 • n=22 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
147.45 mm
STANDARD_DEVIATION 78.71 • n=43 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
Diameter Stenosis, %
|
97.59 %
STANDARD_DEVIATION 6.69 • n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
96.33 %
STANDARD_DEVIATION 8.64 • n=29 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
96.90 %
STANDARD_DEVIATION 7.77 • n=53 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
Reference vessel diameter, mm
|
2.80 mm
STANDARD_DEVIATION 0.54 • n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
2.71 mm
STANDARD_DEVIATION 0.39 • n=29 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
2.75 mm
STANDARD_DEVIATION 0.46 • n=53 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
Minimum lumen diameter, mm
|
0.06 mm
STANDARD_DEVIATION 0.19 • n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
0.09 mm
STANDARD_DEVIATION 0.21 • n=29 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
0.08 mm
STANDARD_DEVIATION 0.20 • n=53 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
Calcification
|
13 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
12 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
25 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Calcification - mild/moderate
|
3 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
4 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
7 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Calcification - moderate/severe
|
8 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
4 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
12 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
Calcification - severe
|
2 Lesions
n=24 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
4 Lesions
n=29 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
6 Lesions
n=53 Lesions • Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement.
|
|
TASC II - A
|
1 Lesions
n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
0 Lesions
n=29 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
1 Lesions
n=53 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
TASC II - B
|
1 Lesions
n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
4 Lesions
n=29 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
5 Lesions
n=53 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
TASC II - C
|
16 Lesions
n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
17 Lesions
n=29 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
33 Lesions
n=53 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
|
TASC II - D
|
6 Lesions
n=24 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
8 Lesions
n=29 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
14 Lesions
n=53 Lesions • Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement.
|
PRIMARY outcome
Timeframe: 9 MonthsPopulation: 3 participants were missing data in IN.PACT 014 arm, and 3 participants were missing data in the PTA arm.
Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=20 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=24 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months
|
0.892 mm
Standard Deviation 0.774
|
1.312 mm
Standard Deviation 0.720
|
SECONDARY outcome
Timeframe: 9 MonthsA composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=24 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Composite Safety Endpoint
|
21 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: through 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: number analyzed in one or more rows indicates the number analyzed at each timepoint
defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Major Adverse Event (MAE) Rate
through 3 months
|
95.45 probability
Interval 87.14 to 100.0
|
96.30 probability
Interval 89.43 to 100.0
|
|
Major Adverse Event (MAE) Rate
through 6 months
|
95.45 probability
Interval 87.14 to 100.0
|
88.89 probability
Interval 77.79 to 100.0
|
|
Major Adverse Event (MAE) Rate
through 9 months
|
86.36 probability
Interval 73.15 to 100.0
|
85.19 probability
Interval 72.79 to 99.7
|
|
Major Adverse Event (MAE) Rate
through 12 months
|
81.82 probability
Interval 67.19 to 99.63
|
77.78 probability
Interval 63.58 to 95.15
|
|
Major Adverse Event (MAE) Rate
through 24 months
|
54.55 probability
Interval 37.25 to 79.88
|
70.37 probability
Interval 55.09 to 89.88
|
|
Major Adverse Event (MAE) Rate
through 36 months
|
45.45 probability
Interval 28.76 to 71.84
|
62.96 probability
Interval 47.15 to 84.09
|
|
Major Adverse Event (MAE) Rate
through 48 months
|
45.45 probability
Interval 28.76 to 71.84
|
51.16 probability
Interval 35.23 to 74.28
|
|
Major Adverse Event (MAE) Rate
through 60 months
|
45.45 probability
Interval 28.76 to 71.84
|
46.89 probability
Interval 31.12 to 70.67
|
SECONDARY outcome
Timeframe: at 3, 6, 9, 12, 24 and 36 monthsPopulation: Participant analysis not performed, as this is a lesion-based measurement.
is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=24 Lesions
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=29 Lesions
Participants who receive standard PTA treatment
|
|---|---|---|
|
Functional Flow Assessment
At 3 Months
|
15 Lesions
|
14 Lesions
|
|
Functional Flow Assessment
At 6 Months
|
15 Lesions
|
13 Lesions
|
|
Functional Flow Assessment
At 9 Months
|
11 Lesions
|
6 Lesions
|
|
Functional Flow Assessment
At 12 Months
|
11 Lesions
|
5 Lesions
|
|
Functional Flow Assessment
At 24 Months
|
6 Lesions
|
10 Lesions
|
|
Functional Flow Assessment
At 36 Months
|
9 Lesions
|
6 Lesions
|
SECONDARY outcome
Timeframe: through 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: number analyzed in one or more rows indicates the number analyzed at each timepoint
Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Death of Any Cause
Through 3 months
|
100.0 probability
Interval 100.0 to 100.0
|
96.30 probability
Interval 89.43 to 100.0
|
|
Death of Any Cause
Through 6 months
|
100.0 probability
Interval 100.0 to 100.0
|
92.59 probability
Interval 83.22 to 100.0
|
|
Death of Any Cause
Through 9 months
|
95.45 probability
Interval 87.14 to 100.0
|
92.59 probability
Interval 83.22 to 100.0
|
|
Death of Any Cause
Through 48 months
|
59.09 probability
Interval 41.74 to 83.66
|
73.89 probability
Interval 58.98 to 92.56
|
|
Death of Any Cause
Through 60 months
|
59.09 probability
Interval 41.74 to 83.66
|
65.68 probability
Interval 49.72 to 86.75
|
|
Death of Any Cause
Through 12 months
|
95.45 probability
Interval 87.14 to 100.0
|
88.89 probability
Interval 77.79 to 100.0
|
|
Death of Any Cause
Through 24 months
|
72.73 probability
Interval 56.31 to 93.94
|
88.89 probability
Interval 77.79 to 100.0
|
|
Death of Any Cause
Through 36 months
|
68.18 probability
Interval 51.25 to 90.71
|
77.78 probability
Interval 63.58 to 95.15
|
SECONDARY outcome
Timeframe: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: number analyzed in one or more rows indicates the number analyzed at each timepoint
Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Major Target Limb Amputation Rate
Through 30 days
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 3 months
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 6 months
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 9 months
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 12 months
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 24 months
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 36 months
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 48 months
|
100.00 probability
Interval 100.0 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Major Target Limb Amputation Rate
Through 60 months
|
100.00 probability
Interval 100.0 to 100.0
|
93.75 probability
Interval 82.61 to 100.0
|
SECONDARY outcome
Timeframe: through 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: number analyzed in one or more rows indicates the number analyzed at each timepoint
Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 3 months
|
95.45 probability
Interval 87.14 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 6 months
|
95.45 probability
Interval 87.14 to 100.0
|
96.15 probability
Interval 89.04 to 100.0
|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 12 months
|
85.91 probability
Interval 72.32 to 100.0
|
88.14 probability
Interval 76.39 to 100.0
|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 24 months
|
80.86 probability
Interval 65.59 to 99.67
|
79.75 probability
Interval 65.34 to 97.33
|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 36 months
|
73.51 probability
Interval 55.52 to 97.31
|
79.75 probability
Interval 65.34 to 97.33
|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 48 months
|
73.51 probability
Interval 55.52 to 97.31
|
69.78 probability
Interval 53.16 to 91.6
|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 60 months
|
73.51 probability
Interval 55.52 to 97.31
|
69.78 probability
Interval 53.16 to 91.6
|
|
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Through 9 months
|
90.68 probability
Interval 79.17 to 100.0
|
92.15 probability
Interval 82.27 to 100.0
|
SECONDARY outcome
Timeframe: through 37 daysPopulation: Number of subjects undergo MD-TLR within 37 days post-index procedure adjudicated by CEC divided by the number of evaluable subjects at 37 days.
Mechanically-driven Target Lesion Revascularization (TLR) rate
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=26 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Mechanically-driven Target Lesion Revascularization (TLR) Rate
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: through 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: Number analyzed in one or more rows indicates the number analyzed at each timepoint
Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Target Lesion Revascularization (TLR) Rate
Through 9 months
|
90.87 probability
Interval 79.55 to 100.0
|
84.13 probability
Interval 71.01 to 99.69
|
|
Target Lesion Revascularization (TLR) Rate
Through 12 months
|
86.09 probability
Interval 72.62 to 100.0
|
80.13 probability
Interval 65.95 to 97.35
|
|
Target Lesion Revascularization (TLR) Rate
Through 24 months
|
81.02 probability
Interval 65.84 to 99.71
|
71.69 probability
Interval 55.92 to 91.91
|
|
Target Lesion Revascularization (TLR) Rate
Through 36 months
|
73.66 probability
Interval 55.71 to 97.38
|
71.69 probability
Interval 55.92 to 91.91
|
|
Target Lesion Revascularization (TLR) Rate
Through 48 months
|
73.66 probability
Interval 55.71 to 97.38
|
62.13 probability
Interval 45.21 to 85.39
|
|
Target Lesion Revascularization (TLR) Rate
Through 60 months
|
73.66 probability
Interval 55.71 to 97.38
|
62.13 probability
Interval 45.21 to 85.39
|
|
Target Lesion Revascularization (TLR) Rate
Through 3 months
|
95.65 probability
Interval 87.67 to 100.0
|
100.00 probability
Interval 100.0 to 100.0
|
|
Target Lesion Revascularization (TLR) Rate
Through 6 months
|
95.65 probability
Interval 87.67 to 100.0
|
96.15 probability
Interval 89.04 to 100.0
|
SECONDARY outcome
Timeframe: through 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: number analyzed in one or more rows indicates the number analyzed at each timepoint
Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 3 months
|
95.45 probability
Interval 87.14 to 100.0
|
96.15 probability
Interval 89.04 to 100.0
|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 6 months
|
95.45 probability
Interval 87.14 to 100.0
|
92.31 probability
Interval 82.61 to 100.0
|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 9 months
|
90.68 probability
Interval 79.17 to 100.0
|
88.29 probability
Interval 76.68 to 100.0
|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 24 months
|
80.86 probability
Interval 65.59 to 99.67
|
75.85 probability
Interval 60.71 to 94.77
|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 36 months
|
73.51 probability
Interval 55.52 to 97.31
|
75.85 probability
Interval 60.71 to 94.77
|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 48 months
|
73.51 probability
Interval 55.52 to 97.31
|
65.74 probability
Interval 48.79 to 88.58
|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 60 months
|
73.51 probability
Interval 55.52 to 97.31
|
65.74 probability
Interval 48.79 to 88.58
|
|
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Through 12 months
|
85.91 probability
Interval 72.32 to 100.0
|
84.28 probability
Interval 71.25 to 99.7
|
SECONDARY outcome
Timeframe: through 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: number analyzed in one or more rows indicates the number analyzed at each timepoint
Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Target Vessel Revascularization (TVR) Rate
Through 3 months
|
95.65 probability
Interval 87.67 to 100.0
|
96.15 probability
Interval 89.04 to 100.0
|
|
Target Vessel Revascularization (TVR) Rate
Through 6 months
|
95.65 probability
Interval 87.67 to 100.0
|
92.31 probability
Interval 82.61 to 100.0
|
|
Target Vessel Revascularization (TVR) Rate
Through 9 months
|
90.87 probability
Interval 79.55 to 100.0
|
80.27 probability
Interval 66.16 to 97.38
|
|
Target Vessel Revascularization (TVR) Rate
Through 12 months
|
86.09 probability
Interval 72.62 to 100.0
|
76.25 probability
Interval 61.32 to 94.82
|
|
Target Vessel Revascularization (TVR) Rate
Through 24 months
|
81.02 probability
Interval 65.84 to 99.71
|
67.78 probability
Interval 51.62 to 89.0
|
|
Target Vessel Revascularization (TVR) Rate
Through 36 months
|
73.66 probability
Interval 55.71 to 97.38
|
67.78 probability
Interval 51.62 to 89.0
|
|
Target Vessel Revascularization (TVR) Rate
Through 48 months
|
73.66 probability
Interval 55.71 to 97.38
|
58.10 probability
Interval 41.1 to 82.14
|
|
Target Vessel Revascularization (TVR) Rate
Through 60 months
|
73.66 probability
Interval 55.71 to 97.38
|
58.10 probability
Interval 41.1 to 82.14
|
SECONDARY outcome
Timeframe: at 30 days, 3, 6, 9, 12, 24 and 36 monthsPopulation: This is a wound-based measurement. Numbers are % (counts/number of wounds with data). Each participant could report one or more baseline wounds, or none. Therefore, the overall number of participants analyzed may not correspond to the number of wounds analyzed. Number of participants analyzed at each timepoint indicates the number of participants with at least one Baseline Wound. 21 wounds in the IN.PACT 014 arm, and 25 wounds were analyzed in the PTA arm, based on available data.
Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=21 Baseline wounds
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=25 Baseline wounds
Participants who receive standard PTA treatment
|
|---|---|---|
|
Status of Wound Healing
Within 36 Months · Skin graft
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 12 Months · Unchanged
|
0 Baseline wounds
|
2 Baseline wounds
|
|
Status of Wound Healing
Within 30 Days · Completely Healed
|
3 Baseline wounds
|
2 Baseline wounds
|
|
Status of Wound Healing
Within 30 Days · Improvement
|
7 Baseline wounds
|
8 Baseline wounds
|
|
Status of Wound Healing
Within 30 Days · Unchanged
|
0 Baseline wounds
|
3 Baseline wounds
|
|
Status of Wound Healing
Within 30 Days · Worsened
|
0 Baseline wounds
|
1 Baseline wounds
|
|
Status of Wound Healing
Within 30 Days · Amputation
|
11 Baseline wounds
|
11 Baseline wounds
|
|
Status of Wound Healing
Within 30 Days · Skin graft
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 3 Months · Completely Healed
|
5 Baseline wounds
|
7 Baseline wounds
|
|
Status of Wound Healing
Within 3 Months · Improvement
|
4 Baseline wounds
|
4 Baseline wounds
|
|
Status of Wound Healing
Within 3 Months · Unchanged
|
0 Baseline wounds
|
2 Baseline wounds
|
|
Status of Wound Healing
Within 3 Months · Worsened
|
1 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 3 Months · Amputation
|
11 Baseline wounds
|
11 Baseline wounds
|
|
Status of Wound Healing
Within 3 Months · Skin graft
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 6 Months · Completely Healed
|
8 Baseline wounds
|
10 Baseline wounds
|
|
Status of Wound Healing
Within 6 Months · Improvement
|
2 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 6 Months · Unchanged
|
0 Baseline wounds
|
1 Baseline wounds
|
|
Status of Wound Healing
Within 6 Months · Worsened
|
0 Baseline wounds
|
1 Baseline wounds
|
|
Status of Wound Healing
Within 6 Months · Amputation
|
11 Baseline wounds
|
12 Baseline wounds
|
|
Status of Wound Healing
Within 9 Months · Completely Healed
|
9 Baseline wounds
|
10 Baseline wounds
|
|
Status of Wound Healing
Within 9 Months · Improvement
|
1 Baseline wounds
|
1 Baseline wounds
|
|
Status of Wound Healing
Within 9 Months · Unchanged
|
0 Baseline wounds
|
1 Baseline wounds
|
|
Status of Wound Healing
Within 9 Months · Worsened
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 9 Months · Amputation
|
11 Baseline wounds
|
11 Baseline wounds
|
|
Status of Wound Healing
Within 9 Months · Skin graft
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 12 Months · Completely Healed
|
8 Baseline wounds
|
10 Baseline wounds
|
|
Status of Wound Healing
Within 12 Months · Worsened
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 12 Months · Improvement
|
1 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 12 Months · Amputation
|
11 Baseline wounds
|
11 Baseline wounds
|
|
Status of Wound Healing
Within 24 Months · Completely Healed
|
8 Baseline wounds
|
9 Baseline wounds
|
|
Status of Wound Healing
Within 24 Months · Improvement
|
1 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 24 Months · Unchanged
|
0 Baseline wounds
|
2 Baseline wounds
|
|
Status of Wound Healing
Within 24 Months · Worsened
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 24 Months · Amputation
|
11 Baseline wounds
|
11 Baseline wounds
|
|
Status of Wound Healing
Within 24 Months · Skin graft
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 36 Months · Completely Healed
|
6 Baseline wounds
|
9 Baseline wounds
|
|
Status of Wound Healing
Within 36 Months · Improvement
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 36 Months · Unchanged
|
0 Baseline wounds
|
2 Baseline wounds
|
|
Status of Wound Healing
Within 36 Months · Worsened
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 36 Months · Amputation
|
7 Baseline wounds
|
11 Baseline wounds
|
|
Status of Wound Healing
Within 6 Months · Skin graft
|
0 Baseline wounds
|
0 Baseline wounds
|
|
Status of Wound Healing
Within 12 Months · Skin graft
|
0 Baseline wounds
|
0 Baseline wounds
|
SECONDARY outcome
Timeframe: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 monthsPopulation: number analyzed in one or more rows indicates the number analyzed at each timepoint
Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Rate of Thrombosis at the Target Lesion
Through 3 months
|
95.7 probability
Interval 87.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 6 months
|
95.7 probability
Interval 87.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 30 days
|
95.7 probability
Interval 87.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 9 months
|
95.7 probability
Interval 87.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 12 months
|
90.9 probability
Interval 79.5 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 24 months
|
86.1 probability
Interval 72.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 36 months
|
86.1 probability
Interval 72.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 48 months
|
86.1 probability
Interval 72.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
|
Rate of Thrombosis at the Target Lesion
Through 60 months
|
86.1 probability
Interval 72.6 to 100.0
|
96.3 probability
Interval 89.4 to 100.0
|
SECONDARY outcome
Timeframe: at the time of procedurePopulation: 68 IN.PACT 014 Investigational devices used
Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=68 IN.PACT 014 Investigational devices
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
Participants who receive standard PTA treatment
|
|---|---|---|
|
Device Success
|
64 IN.PACT 014 Investigational devices
|
—
|
SECONDARY outcome
Timeframe: up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.]Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis \> 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed.
Outcome measures
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 Participants
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 Participants
Participants who receive standard PTA treatment
|
|---|---|---|
|
Clinical Success
|
12 Participants
|
11 Participants
|
Adverse Events
Drug Coated Balloon IN.PACT 014
Serious events: 19 serious events
Other events: 13 other events
Deaths: 9 deaths
Percutaneous Transluminal Angioplasty (PTA)
Serious events: 25 serious events
Other events: 24 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 participants at risk
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 participants at risk
Participants who receive standard PTA treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
8.7%
2/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
ANGINA UNSTABLE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
CARDIAC ARREST
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
CARDIAC FAILURE
|
21.7%
5/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
8.7%
2/23 • 1800 Days (60 Months)
|
11.1%
3/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
MICROVASCULAR CORONARY ARTERY DISEASE
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Gastrointestinal disorders
FOOD POISONING
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
8.7%
2/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
General disorders
DEATH
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
General disorders
VASCULAR STENT OCCLUSION
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
General disorders
VASCULAR STENT THROMBOSIS
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
ENDOCARDITIS PSEUDOMONAL
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Infections and infestations
GANGRENE
|
4.3%
1/23 • 1800 Days (60 Months)
|
11.1%
3/27 • 1800 Days (60 Months)
|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
KLEBSIELLA INFECTION
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
PNEUMONIA
|
8.7%
2/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
8.7%
2/23 • 1800 Days (60 Months)
|
11.1%
3/27 • 1800 Days (60 Months)
|
|
Infections and infestations
SEPSIS
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Infections and infestations
UROSEPSIS
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Infections and infestations
WOUND INFECTION
|
8.7%
2/23 • 1800 Days (60 Months)
|
11.1%
3/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
8.7%
2/23 • 1800 Days (60 Months)
|
14.8%
4/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
PERIPHERAL ARTERIAL REOCCLUSION
|
13.0%
3/23 • 1800 Days (60 Months)
|
29.6%
8/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
PERIPHERAL ARTERY RESTENOSIS
|
13.0%
3/23 • 1800 Days (60 Months)
|
14.8%
4/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
13.0%
3/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC GASTRIC CANCER
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Nervous system disorders
SPONDYLITIC MYELOPATHY
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Nervous system disorders
SYNCOPE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Product Issues
DEVICE DEFECTIVE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
4.3%
1/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Skin and subcutaneous tissue disorders
DIABETIC WOUND
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Skin and subcutaneous tissue disorders
ISCHAEMIC SKIN ULCER
|
4.3%
1/23 • 1800 Days (60 Months)
|
22.2%
6/27 • 1800 Days (60 Months)
|
|
Skin and subcutaneous tissue disorders
SKIN NECROSIS
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
13.0%
3/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Surgical and medical procedures
CARDIAC PACEMAKER REPLACEMENT
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Surgical and medical procedures
PERIPHERAL ARTERY ANGIOPLASTY
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Vascular disorders
AORTIC ANEURYSM RUPTURE
|
4.3%
1/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Vascular disorders
EXTREMITY NECROSIS
|
4.3%
1/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Vascular disorders
ISCHAEMIA
|
0.00%
0/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
4.3%
1/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERY OCCLUSION
|
21.7%
5/23 • 1800 Days (60 Months)
|
29.6%
8/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
8.7%
2/23 • 1800 Days (60 Months)
|
14.8%
4/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
|
17.4%
4/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
13.0%
3/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
Other adverse events
| Measure |
Drug Coated Balloon IN.PACT 014
n=23 participants at risk
Participants who receive IN.PACT 014
|
Percutaneous Transluminal Angioplasty (PTA)
n=27 participants at risk
Participants who receive standard PTA treatment
|
|---|---|---|
|
General disorders
IMPAIRED HEALING
|
4.3%
1/23 • 1800 Days (60 Months)
|
7.4%
2/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/23 • 1800 Days (60 Months)
|
14.8%
4/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
PERIPHERAL ARTERIAL REOCCLUSION
|
8.7%
2/23 • 1800 Days (60 Months)
|
22.2%
6/27 • 1800 Days (60 Months)
|
|
Injury, poisoning and procedural complications
PERIPHERAL ARTERY RESTENOSIS
|
8.7%
2/23 • 1800 Days (60 Months)
|
18.5%
5/27 • 1800 Days (60 Months)
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/23 • 1800 Days (60 Months)
|
11.1%
3/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
|
8.7%
2/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERY DISSECTION
|
8.7%
2/23 • 1800 Days (60 Months)
|
0.00%
0/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERY OCCLUSION
|
8.7%
2/23 • 1800 Days (60 Months)
|
11.1%
3/27 • 1800 Days (60 Months)
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
8.7%
2/23 • 1800 Days (60 Months)
|
3.7%
1/27 • 1800 Days (60 Months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER