Trial Outcomes & Findings for Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis (NCT NCT02063672)
NCT ID: NCT02063672
Last Updated: 2019-04-11
Results Overview
Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
12 Months
Results posted on
2019-04-11
Participant Flow
Participant milestones
| Measure |
Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
29
|
|
Overall Study
COMPLETED
|
18
|
7
|
|
Overall Study
NOT COMPLETED
|
35
|
22
|
Reasons for withdrawal
| Measure |
Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Overall Study
Ongoing Follow-up
|
27
|
14
|
|
Overall Study
Death
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
Baseline characteristics by cohort
| Measure |
Lutonix DCB
n=53 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=29 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 8.64 • n=7 Participants
|
68.2 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: All subjects who completed a 12-Month follow-up visit
Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.
Outcome measures
| Measure |
Lutonix DCB
n=49 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=23 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants With Primary Patency at 1 Year
|
67.0 Percentage of Participants
Interval 50.5 to 79.1
|
49.5 Percentage of Participants
Interval 26.2 to 69.2
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: All participants with 12-month evaluable data for the primary safety endpoint.
Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year
Outcome measures
| Measure |
Lutonix DCB
n=40 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=16 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Primary Safety Events
|
72.8 Percentage of Participants
Interval 58.4 to 82.9
|
64.0 Percentage of Participants
Interval 42.0 to 79.5
|
SECONDARY outcome
Timeframe: During the Index Procedure (90 mins)Population: All participants with evaluable data
Device success is defined as, on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.
Outcome measures
| Measure |
Lutonix DCB
n=53 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=28 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants With Device Success
|
98.1 Percentage of Participants
Interval 89.9 to 100.0
|
100 Percentage of Participants
Interval 87.7 to 100.0
|
SECONDARY outcome
Timeframe: During the Index Procedure (90 mins)Technical success of the balloon procedure is defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion and a successful withdrawal of the study system with the achievement of \< 30% residual percent stenosis without deployment of a bail-out stent.
Outcome measures
| Measure |
Lutonix DCB
n=50 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=27 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants With Technical Success
|
66.0 Percentage of Participants
Interval 51.2 to 78.8
|
77.8 Percentage of Participants
Interval 57.7 to 91.4
|
SECONDARY outcome
Timeframe: During the Index Procedure (90 mins)Population: All participants with evaluable data.
Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, amputation of the target limb, or repeat revascularization of the target lesion) during the index procedure and through the hospital stay.
Outcome measures
| Measure |
Lutonix DCB
n=50 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=27 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants With Procedural Success
|
70.0 Percentage of Participants
Interval 55.4 to 82.1
|
77.8 Percentage of Participants
Interval 57.7 to 91.4
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants with evaluable data at each time point.
Primary Patency is defined as Freedom from CEC-adjudicated Clinically-Driven TLR and from Core laboratory-adjudicated Binary Restenosis. Binary restenosis is based on threshold Doppler peak systolic velocity ratio (PSVR) ≥ 2.5 (together with waveform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).
Outcome measures
| Measure |
Lutonix DCB
n=43 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=20 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants With Primary Patency at 6 and 12 Months
6 Months
|
92.1 Percentage of Participants
Interval 80.2 to 96.9
|
77.0 Percentage of Participants
Interval 53.1 to 89.8
|
|
Percentage of Participants With Primary Patency at 6 and 12 Months
12 Months
|
67.0 Percentage of Participants
Interval 50.5 to 79.1
|
37.1 Percentage of Participants
Interval 16.1 to 58.4
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants with evaluable data.
Secondary patency is defined as the absence of Binary Restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.
Outcome measures
| Measure |
Lutonix DCB
n=33 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=10 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants With Secondary Patency at 6 Months and 12 Months
6 Months
|
90.9 Percentage of Participants
Interval 75.7 to 98.1
|
60.0 Percentage of Participants
Interval 26.2 to 87.8
|
|
Percentage of Participants With Secondary Patency at 6 Months and 12 Months
12 Months
|
74.2 Percentage of Participants
Interval 55.4 to 88.1
|
80.0 Percentage of Participants
Interval 44.4 to 97.5
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants with evaluable data.
Clinically-driven TLR is defined as revascularization of the target vessel with evidence of target vessel diameter stenosis \>50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms), OR revascularization of a target vessel with an in-lesion diameter stenosis of \>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.
Outcome measures
| Measure |
Lutonix DCB
n=50 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=26 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)
12 Months
|
78.6 Percentage of Participants
Interval 64.7 to 87.5
|
64.0 Percentage of Participants
Interval 42.0 to 79.5
|
|
Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)
6 Months
|
94.3 Percentage of Participants
Interval 83.4 to 98.1
|
96.4 Percentage of Participants
Interval 77.2 to 99.5
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants with evaluable data.
TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.
Outcome measures
| Measure |
Lutonix DCB
n=50 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=26 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Target Lesion Revascularization (TLR)
6 Months
|
94.3 Percentage of Participants
Interval 83.4 to 98.1
|
92.7 Percentage of Participants
Interval 73.9 to 98.1
|
|
Percentage of Participants Without Target Lesion Revascularization (TLR)
12 Months
|
78.6 Percentage of Participants
Interval 64.7 to 87.5
|
64.0 Percentage of Participants
Interval 42.0 to 79.5
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants with evaluable data
Sustained clinical benefit is defined as an improvement in Rutherford Classification compared to baseline and freedom from target vessel revascularization. The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.
Outcome measures
| Measure |
Lutonix DCB
n=49 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=22 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants With Sustained Clinical Benefit Compared to Baseline
6 Months
|
69.4 Percentage of Participants
Interval 54.6 to 81.7
|
59.1 Percentage of Participants
Interval 36.4 to 79.3
|
|
Percentage of Participants With Sustained Clinical Benefit Compared to Baseline
12 Months
|
61.2 Percentage of Participants
Interval 46.2 to 74.8
|
50.0 Percentage of Participants
Interval 28.2 to 71.8
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All patients with evaluable data.
The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.
Outcome measures
| Measure |
Lutonix DCB
n=49 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=22 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Change of Rutherford Classification From Baseline
6 Months
|
-1.7 units on a scale
Standard Deviation 1.26
|
-1.5 units on a scale
Standard Deviation 1.41
|
|
Change of Rutherford Classification From Baseline
12 Months
|
-1.6 units on a scale
Standard Deviation 1.17
|
-1.9 units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants with evaluable data
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).
Outcome measures
| Measure |
Lutonix DCB
n=39 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=17 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Change of Resting Ankle Brachial Index (ABI) From Baseline
6 Months
|
0.20 ratio
Standard Deviation 0.20
|
0.25 ratio
Standard Deviation 0.30
|
|
Change of Resting Ankle Brachial Index (ABI) From Baseline
12 Months
|
0.16 ratio
Standard Deviation 0.20
|
0.16 ratio
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: All participants with evaluable data
The Walking Impairment Questionnaire (WIQ) is a validated questionnaire that evaluates walking ability with a focus on walking distance, walking speed, and the ability to climb stairs. Participants answer each item on a Likert scale from 0 for "unable to do" to 4 for "no difficulty", and each response is weighted based on the difficulty of the task. The overall score is determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. The overall score ranges from 0-100 with lower scores indicating lower performance.
Outcome measures
| Measure |
Lutonix DCB
n=49 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=23 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Change in Walking Impairment Questionnaire From Baseline
12 Months
|
12.7 units on a scale
Standard Deviation 22.6
|
12.7 units on a scale
Standard Deviation 27.7
|
|
Change in Walking Impairment Questionnaire From Baseline
6 Months
|
14.9 units on a scale
Standard Deviation 28.6
|
16.0 units on a scale
Standard Deviation 38.3
|
SECONDARY outcome
Timeframe: 6 months and 12 MonthsPopulation: All participants with evaluable data
EQ-5D is a standardized tool to assess patient-reported mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, or slight, moderate, severe, or extreme problems. Patients choose the appropriate level in each of the 5 dimensions, which results in a 1-digit number for each dimension. The digits for the 5 dimensions are converted into a single EQ-5D™ index score based on a set of population-based preference weights. For the U.S. general population, possible EQ-5D™ index scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. A downloadable scoring file is available at: https://www.ahrq.gov/rice/EQ5Dscore.htm. The EQ VAS records a patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). A higher VAS value indicates a higher quality of life.
Outcome measures
| Measure |
Lutonix DCB
n=49 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=23 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Change in Quality of Life From Baseline
6 Months - EQ5D Index
|
0.1 units on a scale
Standard Deviation 0.18
|
0.0 units on a scale
Standard Deviation 0.24
|
|
Change in Quality of Life From Baseline
12 Months - EQ5D Index
|
0.0 units on a scale
Standard Deviation 0.19
|
0.0 units on a scale
Standard Deviation 0.23
|
|
Change in Quality of Life From Baseline
6 Months - EQ5D VAS
|
-2.0 units on a scale
Standard Deviation 23.1
|
0.3 units on a scale
Standard Deviation 23.2
|
|
Change in Quality of Life From Baseline
12 Months - EQ5D VAS
|
2.9 units on a scale
Standard Deviation 23.0
|
0.5 units on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: All participants with evaluable data
Freedom from major vascular complications at 30 days follow-up
Outcome measures
| Measure |
Lutonix DCB
n=52 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=28 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Major Vascular Complications (≤30 Day)
|
98.1 Percentage of Participants
Interval 89.7 to 100.0
|
92.9 Percentage of Participants
Interval 76.5 to 99.1
|
SECONDARY outcome
Timeframe: 1 month, 6 months, and 12 monthsPopulation: All participants with evaluable data
Mortality from any cause.
Outcome measures
| Measure |
Lutonix DCB
n=52 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=28 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without All-Cause Death
1 Month
|
100 Percentage of Participants
100% value, CI not applicable
|
100 Percentage of Participants
100% value, CI not applicable
|
|
Percentage of Participants Without All-Cause Death
6 Months
|
100 Percentage of Participants
100% value, CI not applicable
|
96.4 Percentage of Participants
Interval 77.2 to 99.5
|
|
Percentage of Participants Without All-Cause Death
12 Months
|
100 Percentage of Participants
100% value, CI not applicable
|
96.4 Percentage of Participants
Interval 77.2 to 99.5
|
SECONDARY outcome
Timeframe: 1 month, 6 months, and 12 monthsPopulation: All participants with evaluable data
Major limb amputation is defined as amputation of the lower limb above the ankle.
Outcome measures
| Measure |
Lutonix DCB
n=52 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=28 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Major Limb Amputation
6 Months
|
100 Percentage of Participants
100% Value, CI is not needed
|
100 Percentage of Participants
100% Value, CI is not needed
|
|
Percentage of Participants Without Major Limb Amputation
1 Month
|
100 Percentage of Participants
100% Value, CI not calculable
|
100 Percentage of Participants
100% Value, CI not calculable
|
|
Percentage of Participants Without Major Limb Amputation
12 Months
|
100 Percentage of Participants
100% Value, CI not calculable
|
100 Percentage of Participants
100% Value, CI not calculable
|
SECONDARY outcome
Timeframe: 1 month, 6 months, and 12 monthsPopulation: All participants with evaluable data
Minor limb amputation is defined as amputation of a part of the foot below the ankle.
Outcome measures
| Measure |
Lutonix DCB
n=52 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=28 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Minor Limb Amputation
1 Month
|
100 Percentage of Participants
100% Value, CI not calculable
|
100 Percentage of Participants
100% Value, CI not calculable
|
|
Percentage of Participants Without Minor Limb Amputation
6 Months
|
100 Percentage of Participants
100% Value, CI not calculable
|
96.4 Percentage of Participants
Interval 77.2 to 99.5
|
|
Percentage of Participants Without Minor Limb Amputation
12 Months
|
100 Percentage of Participants
100% Value, CI not calculable
|
96.4 Percentage of Participants
Interval 77.2 to 99.5
|
SECONDARY outcome
Timeframe: 1 month, 6 months, and 12 monthsPopulation: All participants with evaluable data
A TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel.
Outcome measures
| Measure |
Lutonix DCB
n=50 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=28 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Target Vessel Revascularizations (TVR)
1 Month
|
96.2 Percentage of Participants
Interval 85.7 to 99.0
|
100 Percentage of Participants
100% Value, CI not calculable
|
|
Percentage of Participants Without Target Vessel Revascularizations (TVR)
6 Months
|
90.5 Percentage of Participants
Interval 78.6 to 95.9
|
92.7 Percentage of Participants
Interval 73.9 to 98.1
|
|
Percentage of Participants Without Target Vessel Revascularizations (TVR)
12 Months
|
76.7 Percentage of Participants
Interval 62.6 to 86.0
|
64.0 Percentage of Participants
Interval 42.0 to 79.5
|
SECONDARY outcome
Timeframe: 1 month, 6 months, and 12 monthsPopulation: All participants with evaluable data
Any surgical intervention in the target limb.
Outcome measures
| Measure |
Lutonix DCB
n=50 Participants
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=28 Participants
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Percentage of Participants Without Any Target Limb Reinterventions
1 Month
|
96.2 Percentage of Participants
Interval 85.7 to 99.0
|
100 Percentage of Participants
100% Value, CI not calculable
|
|
Percentage of Participants Without Any Target Limb Reinterventions
6 Month
|
88.5 Percentage of Participants
Interval 76.2 to 94.7
|
92.7 Percentage of Participants
Interval 73.9 to 98.1
|
|
Percentage of Participants Without Any Target Limb Reinterventions
12 Month
|
72.8 Percentage of Participants
Interval 58.4 to 82.9
|
64.0 Percentage of Participants
Interval 42.0 to 79.5
|
Adverse Events
Lutonix DCB
Serious events: 44 serious events
Other events: 21 other events
Deaths: 5 deaths
PTA Catheter
Serious events: 17 serious events
Other events: 13 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Lutonix DCB
n=53 participants at risk
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=29 participants at risk
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/53 • Up to 36 Months
|
6.9%
2/29 • Number of events 2 • Up to 36 Months
|
|
Cardiac disorders
Angina pectoris
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
3.4%
1/29 • Number of events 2 • Up to 36 Months
|
|
Cardiac disorders
Angina unstable
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Cardiac disorders
Cardiac failure congestive
|
5.7%
3/53 • Number of events 3 • Up to 36 Months
|
6.9%
2/29 • Number of events 2 • Up to 36 Months
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
General disorders
Asthenia
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
General disorders
Catheter site haematoma
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
General disorders
Death
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
General disorders
Device occlusion
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
General disorders
Non-cardiac chest pain
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
General disorders
Thrombosis in device
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Hepatobiliary disorders
Cryptogenic cirrhosis
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 2 • Up to 36 Months
|
|
Infections and infestations
Cellulitis
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Infections and infestations
Escherichia infection
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Infections and infestations
Gangrene
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Infections and infestations
Klebsiella infection
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Infections and infestations
Localised infection
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Infections and infestations
Osteomyelitis
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Infections and infestations
Pneumonia
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Infections and infestations
Sepsis
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.9%
1/53 • Number of events 2 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
28.3%
15/53 • Number of events 19 • Up to 36 Months
|
27.6%
8/29 • Number of events 12 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 2 • Up to 36 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Nervous system disorders
Intracranial aneurysm
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Nervous system disorders
Syncope
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Psychiatric disorders
Mental status changes
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Vascular disorders
chronicl total occlusion of anterior tibial artery
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Vascular disorders
Femoral artery occlusion
|
5.7%
3/53 • Number of events 3 • Up to 36 Months
|
10.3%
3/29 • Number of events 4 • Up to 36 Months
|
|
Vascular disorders
Hypertension
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Vascular disorders
Hypotension
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Vascular disorders
Intermittent claudication
|
15.1%
8/53 • Number of events 9 • Up to 36 Months
|
20.7%
6/29 • Number of events 6 • Up to 36 Months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Vascular disorders
Peripheral artery dissection
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Vascular disorders
Peripheral artery stenosis
|
13.2%
7/53 • Number of events 8 • Up to 36 Months
|
13.8%
4/29 • Number of events 5 • Up to 36 Months
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.9%
1/53 • Number of events 1 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Vascular disorders
Peripheral vascular disorder
|
3.8%
2/53 • Number of events 2 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Vascular disorders
Varicose vein
|
0.00%
0/53 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
Other adverse events
| Measure |
Lutonix DCB
n=53 participants at risk
Lutonix Paclitaxel Drug Coated Balloon
Lutonix DCB
|
PTA Catheter
n=29 participants at risk
Standard Uncoated Balloon Angioplasty Catheter
Standard Uncoated Balloon Angioplasty Catheter: PTA Catheter
|
|---|---|---|
|
General disorders
Device occlusion
|
0.00%
0/53 • Up to 36 Months
|
6.9%
2/29 • Number of events 2 • Up to 36 Months
|
|
Infections and infestations
Urinary tract infection
|
5.7%
3/53 • Number of events 3 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
11.3%
6/53 • Number of events 9 • Up to 36 Months
|
13.8%
4/29 • Number of events 5 • Up to 36 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
4/53 • Number of events 6 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • Up to 36 Months
|
6.9%
2/29 • Number of events 2 • Up to 36 Months
|
|
Vascular disorders
Femoral artery dissection
|
7.5%
4/53 • Number of events 4 • Up to 36 Months
|
0.00%
0/29 • Up to 36 Months
|
|
Vascular disorders
Peripheral artery stenosis
|
7.5%
4/53 • Number of events 4 • Up to 36 Months
|
3.4%
1/29 • Number of events 1 • Up to 36 Months
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/53 • Up to 36 Months
|
6.9%
2/29 • Number of events 2 • Up to 36 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60