Trial Outcomes & Findings for Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries (NCT NCT01412541)

NCT ID: NCT01412541

Last Updated: 2020-05-12

Results Overview

Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 532 participants
• Primary outcome timeframe: 12 months post index procedure
• Results posted on: 2020-05-12

Participant Flow

Participant milestones

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Overall Study STARTED	372	160
Overall Study COMPLETED	246	117
Overall Study NOT COMPLETED	126	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries

Baseline characteristics by cohort

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Total n=532 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 10.0 • n=5 Participants	69.0 years STANDARD_DEVIATION 9.0 • n=7 Participants	68.2 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	145 Participants n=5 Participants	53 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	227 Participants n=5 Participants	107 Participants n=7 Participants	334 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=335 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=146 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure	85.4 Percentage of participants Interval 81.6 to 89.2	79.5 Percentage of participants Interval 72.9 to 86.0

PRIMARY outcome

Timeframe: 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=314 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=137 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure	66.6 Percentage of participants Interval 61.3 to 71.8	54.0 Percentage of participants Interval 45.7 to 62.4

SECONDARY outcome

Timeframe: At time of Index Procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Device Success was defined as 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 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=432 Devices Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=180 Devices Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Acute Device Success at Time of Index Procedure	430 Devices	180 Devices

SECONDARY outcome

Timeframe: At time of Index Procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Technical Success is defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent.

Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Participants With Technical and Procedural Success Technical Success	282 Participants	138 Participants
Number of Participants With Technical and Procedural Success Procedural Success	281 Participants	138 Participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Primary Patency is defined as the absence of target lesion restenosis (defined by core lab adjudication or strict application of PSVR thresholds) and freedom from target lesion revascularization (TLR).

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	263 Participants	92 Participants
Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	209 Participants	74 Participants
Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure 24 months post index procedure	160 Participants	60 Participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 and <3.0 at 6, 12, and 24 months post index procedure. DUS PSVR was calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure DUS PSVR <2.0 : 6 months post index procedure	220 Participants	74 Participants
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure DUS PSVR <2.0 : 12 months post index procedure	158 Participants	62 Participants
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure DUS PSVR <2.0 : 24 months post index procdure	106 Participants	38 Participants
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure DUS PSVR <3.0 : 6 months post index procedure	259 Participants	98 Participants
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure DUS PSVR <3.0 : 12 months post index procedure	197 Participants	73 Participants
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure DUS PSVR <3.0 : 24 months post index procdure	131 Participants	48 Participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months post index porcedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

DUS Clinical Patency defined as DUS PSVR <2.5 without prior clinically driven target lesion revascularization (TLR).

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	252 Participants	90 Participants
Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	188 Participants	69 Participants
Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure 24 months post index procedure	123 Participants	42 Participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	329 Participants	144 Participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	296 Participants	122 Participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure 24 months post index procedure	250 Participants	104 Participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 24 months from baseline · Same	31 Participants	15 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 6 months from baseline · Improved	290 Participants	118 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 6 months from baseline · Same	30 Participants	22 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 6 months from baseline · Worsened	13 Participants	5 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 12 months from baseline · Improved	273 Participants	108 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 12 months from baseline · Same	27 Participants	21 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 12 months from baseline · Worsened	9 Participants	2 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 24 months from baseline · Improved	242 Participants	106 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 24 months from baseline · Worsened	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months from baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline 6 months post index procedure	0.20 Index Standard Deviation 0.24	0.16 Index Standard Deviation 0.22
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline 12 months post index procedure	0.18 Index Standard Deviation 0.24	0.18 Index Standard Deviation 0.25
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline 24 months post index procedure	0.14 Index Standard Deviation 0.27	0.17 Index Standard Deviation 0.24

SECONDARY outcome

Timeframe: 6, 12, and 24 months from baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The data bellow is presented as a Mean change in scores for the Six Minute Walk Test scores at 6, 12, and 24 months compared to baseline.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline 6 months from baseline	42.5 Meters Standard Deviation 205.7	61.1 Meters Standard Deviation 213.4
Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline 12 months from baseline	45.0 Meters Standard Deviation 227.5	37.4 Meters Standard Deviation 120
Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline 24 months from baseline	48.6 Meters Standard Deviation 190.6	47.1 Meters Standard Deviation 209.2

SECONDARY outcome

Timeframe: 6, 12, and 24 months

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Mean change in EuroQol (EQ-5D) scores at 6, 12, and 24 months compared to baseline. The EurolQol-5D system rates quality of life using five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of ratings, that is, no problems, slight problems, moderate problems, severe problems and extreme problems that can be selected. A visual scale allows participants to report their own perception of their health status. The overall scores range from 0 (worst) to 100 (best). Please note that the data in the table below represent the mean changes in overall scores for each group compared to their baseline data.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. 6 months from baseline	0.08 Score on a scale Standard Deviation 0.21	0.10 Score on a scale Standard Deviation 0.18
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. 12 months from baseline	0.09 Score on a scale Standard Deviation 0.20	0.08 Score on a scale Standard Deviation 0.20
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline. 24 months from baseline	0.07 Score on a scale Standard Deviation 0.23	0.09 Score on a scale Standard Deviation 0.20

SECONDARY outcome

Timeframe: 6, 12, and 24 months

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Mean change from Baseline on the Short Form (SF-36 v2) Quality of Life Questionnaire at 6, 12, and 24 months. The SF-36 v2 United States (US) is a brief measure of general health status. The physical health measure of the test comprises four scales, that is, physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The scores range between 0 and 100 (with higher scores indicating better health). In the results presented below, a positive Mean represents an increase in the average health score while a negative Mean represents a decrease in the same mean score compared to baseline measure.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. 6 months from baseline	6.6 score on a scale Standard Deviation 11.4	6.3 score on a scale Standard Deviation 10.0
Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. 12 months from baseline	6.0 score on a scale Standard Deviation 11.4	5.4 score on a scale Standard Deviation 10.2
Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline. 24 months from baseline	4.5 score on a scale Standard Deviation 11.2	5.2 score on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: 6, 12, and 24 months from baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Mean change in quality of life (mental component) on Short-form 36 (SF-36 v2) from baseline at 6, 12, and 24 months. The SF-36 v2 United States (US) is a brief measure of general health status. The mental health measure comprises four scales, that is, vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). The scores range from 0 to 100 (with higher scores indicating better health). In the results presented below, a positive Mean represents an increase in the average health score while a negative Mean represents a decrease in the same mean score compared to baseline measure.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline 6 months from baseline	-0.7 score on a scale Standard Deviation 12.0	1.6 score on a scale Standard Deviation 14.1
Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline 12 months from baseline	0.2 score on a scale Standard Deviation 12.4	0.4 score on a scale Standard Deviation 13.4
Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline 24 months from baseline	-0.4 score on a scale Standard Deviation 13.0	1.8 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: 30 days post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Number of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=362 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=156 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Porcedure	361 Participants	155 Participants

SECONDARY outcome

Timeframe: 1, 6, 24, 36, 48, and 60 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death 1 month post index procedure	360 Participants	155 Participants
Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death 6 months post index procedure	324 Participants	140 Participants
Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death 24 months post index procedure	240 Participants	94 Participants
Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death 36 months post index procedure	212 Participants	87 Participants
Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death 48 months post index procedure	189 Participants	74 Participants
Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death 60 months post index procedure	160 Participants	69 Participants

SECONDARY outcome

Timeframe: 1, 6, 12, 24, 36, 48, and 60 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Amputation defined as above the ankle free survival (AFS). PPI = Post index procedure.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Cardiovascular Hospitalization : 6 months PPI	20 participants	3 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Minor Amputation : 12 months PPI	0 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Death : 1 month PPI	0 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Amputation : 6 months PPI	1 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Cardiovascular Hospitalization : 48 months PPI	55 participants	23 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Death : 6 months PPI	4 participants	2 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Death : 12 months PPI	10 participants	4 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Death : 24 months PPI	25 participants	8 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Death : 36 months PPI	37 participants	10 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Death : 48 months PPI	54 participants	14 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Cardiovascular Hospitalization : 60 months PPI	55 participants	23 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Vascular Complication : 1 month PPI	15 participants	2 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Vascular Complication : 6 months PPI	19 participants	4 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Vascular Complication : 12 months PPI	22 participants	7 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Vascular Complication : 24 months PPI	32 participants	10 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Death : 60 months PPI	64 participants	17 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Amputation : 1 month PPI	0 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Amputation : 12 months PPI	1 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Amputation : 24 months PPI	1 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Amputation : 36 months PPI	1 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Amputation : 48 months PPI	2 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Amputation : 60 months PPI	2 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Minor Amputation : 1 month PPI	0 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Minor Amputation : 6 months PPI	0 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Minor Amputation : 24 months PPI	1 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Minor Amputation : 36 months PPI	2 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Minor Amputation : 48 months PPI	3 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Minor Amputation : 60 months PPI	3 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Amputation Free Survival : 1 month PPI	362 participants	156 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Amputation Free Survival : 6 months PPI	349 participants	152 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Amputation Free Survival : 12 months PPI	331 participants	144 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Amputation Free Survival : 24 months PPI	301 participants	133 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Vascular Complication : 36 months PPI	36 participants	13 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Amputation Free Survival : 36 months PPI	283 participants	129 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Amputation Free Survival : 48 months PPI	261 participants	122 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Amputation Free Survival : 60 months PPI	242 participants	115 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TLR : 1 month PPI	1 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TLR : 6 months PPI	20 participants	9 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TLR : 12 months PPI	38 participants	24 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Vascular Complication : 48 months PPI	39 participants	13 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TLR : 24 months PPI	59 participants	34 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Major Vascular Complication : 60 months PPI	39 participants	13 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TLR : 36 months PPI	69 participants	38 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TLR : 48 months PPI	78 participants	45 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TLR : 60 months PPI	85 participants	46 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TVR : 1 month PPI	1 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TVR : 6 months PPI	22 participants	12 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TVR : 12 months PPI	42 participants	26 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TVR : 24 months PPI	63 participants	39 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TVR : 36 months PPI	73 participants	43 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TVR : 48 months PPI	83 participants	53 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Total TVR : 60 months PPI	90 participants	54 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Reintervention for Thrombosis : 1 month PPI	1 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Reintervention for Thrombosis : 6 months PPI	1 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Reintervention for Thrombosis : 12 months PPI	1 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Reintervention for Thrombosis : 24 months PPI	1 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Reintervention for Thrombosis : 36 months PPI	2 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Reintervention for Thrombosis : 48 months PPI	2 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Reintervention for Thrombosis : 60 months PPI	2 participants	1 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Cardiovascular Hospitalization : 1 month PPI	1 participants	0 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Cardiovascular Hospitalization : 12 months PPI	31 participants	10 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Cardiovascular Hospitalization : 24 months PPI	52 participants	21 participants
Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI. Cardiovascular Hospitalization : 36 months PPI	55 participants	23 participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 6, 12, and 24 months, compared to baseline assessment scores.

Outcome measures

Measure	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) n=372 Participants Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 Participants Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. 24 months from baseline	22.4 score on a scale Standard Deviation 28.8	16.9 score on a scale Standard Deviation 26.7
Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. 12 months from baseline	23.9 score on a scale Standard Deviation 27.6	19.2 score on a scale Standard Deviation 26.5
Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline. 6 months from baseline	26.6 score on a scale Standard Deviation 28.8	20.5 score on a scale Standard Deviation 28.7

Adverse Events

Lutonix 035 Drug Coated Balloon (Lutonix DCB)

Serious events: 289 serious events

Other events: 316 other events

Deaths: 64 deaths

Standard Uncoated Angioplasty Balloon

Serious events: 125 serious events

Other events: 126 other events

Deaths: 17 deaths

Serious adverse events

Measure	Lutonix 035 Drug Coated Balloon (Lutonix DCB) n=372 participants at risk Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 participants at risk Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
Cardiac disorders Angina, stable	7.5% 28/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.0% 8/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Cardiac disorders Angina, Unstable	2.7% 10/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Cardiac disorders Arrhytmia, Other	3.8% 14/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.2% 10/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Cardiac disorders Chronic heart failure	4.8% 18/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.0% 8/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Cardiac disorders Hypertension	2.7% 10/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.2% 10/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Cardiac disorders Myocardial infarction	6.5% 24/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	10.6% 17/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Cardiac disorders Cardiovascular, Other	15.9% 59/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	12.5% 20/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Gastrointestinal disorders Diarrhea	0.54% 2/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.8% 6/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Gastrointestinal disorders Gastrointestinal bleeding	5.4% 20/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.0% 8/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Gastrointestinal disorders Gastrointestinal, Others	5.9% 22/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.9% 11/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Infections and infestations Local infection	2.2% 8/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.0% 8/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Nervous system disorders Stroke -ischemic	4.0% 15/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.9% 3/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Nervous system disorders Other neurological - nervous system	4.0% 15/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	4.4% 7/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Carcinoma	3.2% 12/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.9% 3/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Other respiratory	5.6% 21/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.8% 6/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Pneumonia	8.6% 32/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	4.4% 7/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Fracture (bone)	3.5% 13/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.2% 10/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Claudication	0.81% 3/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.8% 6/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Other skeletal, spine and muscular system	8.6% 32/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	7.5% 12/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Restenosis	8.6% 32/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	13.8% 22/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Occlusion/closure	1.6% 6/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Renal and urinary disorders Renal failure/ insufficiency	5.4% 20/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.6% 9/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Renal and urinary disorders Urinary infection	2.2% 8/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Renal and urinary disorders Other genito-urinary system	2.7% 10/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
General disorders Carcinoma	7.0% 26/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
General disorders Other	17.5% 65/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	13.1% 21/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Arterial occlusion	3.2% 12/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.6% 9/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Atherosclerosis	4.0% 15/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.9% 11/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Stenosis	11.3% 42/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	14.4% 23/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.

Other adverse events

Measure	Lutonix 035 Drug Coated Balloon (Lutonix DCB) n=372 participants at risk Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	Standard Uncoated Angioplasty Balloon n=160 participants at risk Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
General disorders Hematoma bleeding puncture site minor	6.2% 23/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	2.5% 4/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Angina, Stable	6.2% 23/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.9% 11/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Angina, Unstable	3.2% 12/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.2% 2/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Cardiac disorders Arrythmia - other	3.5% 13/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.2% 10/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Hypertension	5.6% 21/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.6% 9/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Hypotension	3.5% 13/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.9% 3/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Other - Cardiovascular	11.6% 43/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	14.4% 23/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Endocrine disorders Diabetes Melitus Type II	3.2% 12/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	4.4% 7/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Gastrointestinal disorders Nausea	3.5% 13/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.2% 2/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Gastrointestinal disorders Other- gastrointestinal	10.5% 39/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	6.9% 11/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Infections and infestations Infection, local	5.4% 20/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	7.5% 12/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Infections and infestations Other infectious	3.2% 12/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	2.5% 4/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Nervous system disorders Dizziness/ vertigo	5.1% 19/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.6% 9/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Nervous system disorders Other neurological/ nervous system	10.2% 38/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	8.1% 13/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Bronchitis	5.9% 22/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Cough	4.6% 17/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.5% 24/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	4.4% 7/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Other respiratory	9.7% 36/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	11.2% 18/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.3% 16/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	2.5% 4/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 16/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	2.5% 4/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Arthritis	3.8% 14/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.0% 8/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Back pain	12.1% 45/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.0% 8/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Fracture (bone)	4.6% 17/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	4.4% 7/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Claudication	6.5% 24/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	10.6% 17/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Musculoskeletal and connective tissue disorders Other skeletal, spine and muscular system	31.5% 117/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	21.9% 35/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
General disorders Dissection	3.0% 11/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.8% 6/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Restenosis	3.5% 13/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.9% 3/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Restenosis in target vessel	3.8% 14/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.9% 3/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Renal and urinary disorders Renal failure/ insufficiency	5.9% 22/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Renal and urinary disorders Urinary infection	7.0% 26/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	5.6% 9/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Renal and urinary disorders Other, genito-urinary system	6.5% 24/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	8.1% 13/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Skin and subcutaneous tissue disorders Rash	3.2% 12/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
General disorders Other	42.2% 157/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	41.9% 67/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Stenosis	4.0% 15/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	3.1% 5/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.
Vascular disorders Other vessel specific	3.8% 14/372 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.	1.9% 3/160 • 60 months All adverse events occurring in this study will be classified in accordance with the adverse event signs or symptoms. Both Non-Serious Adverse Events (AE) and Serious Adverse Events (SAE) are reported with a threshold of 3%.

Additional Information

Anna Lovas

Becton Dickinson

Phone: 7634452382

Email: anna.lovas@bd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60