Trial Outcomes & Findings for LEVANT 2 Safety Registry (NCT NCT01790243)

NCT ID: NCT01790243

Last Updated: 2020-06-05

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

1189 participants

Primary outcome timeframe

From index procedure to 60 months Post Index Procedure

Results posted on

2020-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Lutonix Drug Coated Balloon Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Overall Study STARTED	1029	160
Overall Study COMPLETED	739	117
Overall Study NOT COMPLETED	290	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LEVANT 2 Safety Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lutonix Drug Coated Balloon n=1029 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=160 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.	Total n=1189 Participants Total of all reporting groups
Age, Continuous	68.4 Years STANDARD_DEVIATION 9.7 • n=99 Participants	69.0 Years STANDARD_DEVIATION 9 • n=107 Participants	68.48 Years STANDARD_DEVIATION 9.5 • n=206 Participants
Sex: Female, Male Female	383 Participants n=99 Participants	53 Participants n=107 Participants	436 Participants n=206 Participants
Sex: Female, Male Male	646 Participants n=99 Participants	107 Participants n=107 Participants	753 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=99 Participants	14 Participants n=107 Participants	53 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	988 Participants n=99 Participants	146 Participants n=107 Participants	1134 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Baseline Rutherford Classification Rutherford 0	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Baseline Rutherford Classification Rutherford 1	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Baseline Rutherford Classification Rutherford 2	354 Participants n=99 Participants	55 Participants n=107 Participants	409 Participants n=206 Participants
Baseline Rutherford Classification Rutherford 3	606 Participants n=99 Participants	92 Participants n=107 Participants	698 Participants n=206 Participants
Baseline Rutherford Classification Rutherford 4	69 Participants n=99 Participants	13 Participants n=107 Participants	82 Participants n=206 Participants
Baseline Rutherford Classification Rutherford 5	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Baseline Rutherford Classification Rutherford 6	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: From index procedure to 60 months Post Index Procedure

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=1029 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=160 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.	0 Participants	0 Participants

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

Outcome measures
Measure	Lutonix Drug Coated Balloon n=1009 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=156 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure	1002 Participants	155 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=1010 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=156 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Cardiovascular Hospitalization : 6 months PPI	53 participants	3 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Cardiovascular Hospitalization : 12 months PPI	88 participants	10 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Cardiovascular Hospitalization : 24 months PPI	112 participants	21 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Cardiovascular Hospitalization : 36 months PPI	115 participants	23 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Cardiovascular Hospitalization : 48 months PPI	115 participants	23 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Cardiovascular Hospitalization : 60 months PPI	115 participants	23 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Vascular Complications : 1 month PPI	27 participants	2 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Vascular Complications : 6 months PPI	39 participants	4 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Vascular Complications : 12 months PPI	51 participants	71 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Vascular Complications : 24 months PPI	79 participants	10 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Vascular Complications : 36 months PPI	87 participants	13 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Vascular Complications : 48 months PPI	92 participants	13 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Vascular Complications : 60 months PPI	93 participants	13 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Death : 1 month post index procedure	1 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Death : 6 months post index procedure	8 participants	2 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Death : 12 months post index procedure	18 participants	4 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Death : 24 months post index procedure	46 participants	8 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Death : 36 months post index procedure	82 participants	10 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Death : 48 months post index procedure	121 participants	14 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Death : 60 months post index procedure	147 participants	17 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Amputation : 1 month post index procedure	0 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Amputation : 6 months post index procedure	1 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Amputation : 12 months post index procedure	1 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Amputation : 24 months post index procedure	2 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Amputation : 36 months post index procedure	3 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Amputation : 48 months post index procedure	6 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Major Amputation : 60 months post index procedure	8 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Minor Amputation : 1 month post index procedure	1 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Minor Amputation : 6 months post index procedure	1 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Minor Amputation : 12 months post index procedure	1 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Minor Amputation : 24 months post index procedure	3 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Minor Amputation : 36 months post index procedure	5 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Minor Amputation : 48 months post index procedure	9 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Minor Amputation : 60 months post index procedure	9 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Amputation Free Survival : 1 month PPI	1008 participants	156 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Amputation Free Survival : 6 months	981 participants	152 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Amputation Free Survival : 12 months PPI	949 participants	144 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Amputation Free Survival : 24 months PPI	881 participants	133 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Amputation Free Survival : 36 months PPI	830 participants	129 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Amputation Free Survival : 48 months PPI	776 participants	122 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Amputation Free Survival : 60 months PPI	729 participants	115 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Target Vessel Revascularization : 1 month PPI	6 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Target Vessel Revascularization : 6 months PPI	48 participants	12 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Target Vessel Revascularization : 12 months PPI	125 participants	26 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Target Vessel Revascularization : 24 months PPI	207 participants	39 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Target Vessel Revascularization : 36 months PPI	240 participants	43 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Target Vessel Revascularization : 48 months PPI	268 participants	53 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Target Vessel Revascularization : 60 months PPI	283 participants	54 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Reintervention for thrombosis : 1 month	2 participants	0 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Reintervention for thrombosis : 6 months	2 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Reintervention for thrombosis : 12 months	3 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Reintervention for thrombosis : 24 months	5 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Reintervention for thrombosis: 36 months	7 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Reintervention for thrombosis : 48 months	7 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Reintervention for thrombosis: 60 months	8 participants	1 participants
Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure Cardiovascular Hospitalization : 1 month PPI	6 participants	0 participants

SECONDARY outcome

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

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

Outcome measures
Measure	Lutonix Drug Coated Balloon n=916 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=142 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	81.4 Percentage of Participants Interval 78.9 to 84.0	64.8 Percentage of Participants Interval 56.9 to 72.6
Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	66.3 Percentage of Participants Interval 63.2 to 69.4	54.0 Percentage of Participants Interval 45.7 to 62.4
Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure 24 months post index procedure	54.5 Percentage of Participants Interval 51.1 to 57.8	47.2 Percentage of Participants Interval 38.6 to 55.9

SECONDARY outcome

Timeframe: At time of index procedure

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

Outcome measures
Measure	Lutonix Drug Coated Balloon n=1404 Devices Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=180 Devices PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Number of Acute Device Success at Time of Index Procedure	1402 Devices	180 Devices

SECONDARY outcome

Timeframe: At time of index procedure

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

Outcome measures
Measure	Lutonix Drug Coated Balloon n=1016 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=159 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Number of Participants With Technical and Procedural Success Technical Success	894 Participants	138 Participants
Number of Participants With Technical and Procedural Success Procedural Success	892 Participants	138 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=981 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=153 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	940 participants	144 participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	839 participants	122 participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure 24-Months Post-Index Procedure	706 participants	104 participants

SECONDARY outcome

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

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

Outcome measures
Measure	Lutonix Drug Coated Balloon n=792 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=136 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
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	565 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	400 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 procedure	282 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	670 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	492 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 procedure	344 Participants	48 Participants

SECONDARY outcome

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

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

Outcome measures
Measure	Lutonix Drug Coated Balloon n=944 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=145 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 6 months from baseline · Improved	830 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	79 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	35 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	771 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	89 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	30 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	701 Participants	106 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 24 months from baseline · Same	88 Participants	15 Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline 24 months from baseline · Worsened	27 Participants	1 Participants

SECONDARY outcome

Timeframe: 6, 12, and 24 months from baseline

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

Outcome measures
Measure	Lutonix Drug Coated Balloon n=892 Participants Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=135 Participants PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline 6 months post index procedure	0.19 Ratio Standard Deviation 0.26	0.16 Ratio 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 Ratio Standard Deviation 0.26	0.18 Ratio 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	0.16 Ratio Standard Deviation 0.27	0.17 Ratio Standard Deviation 0.24

Adverse Events

Lutonix Drug Coated Balloon

Serious events: 813 serious events

Other events: 845 other events

Deaths: 147 deaths

Standard Uncoated Angioplasty Balloon

Serious events: 125 serious events

Other events: 126 other events

Deaths: 17 deaths

Serious adverse events

Other adverse events

Additional Information

Anna Lovas

Becton Dickinson

Phone: 7634452382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Lutonix Drug Coated Balloon n=1029 participants at risk Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.	Standard Uncoated Angioplasty Balloon n=160 participants at risk PTA Catheter Standard PTA Balloon: Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
General disorders Hematoma / bleeding puncture site - minor	5.0% 51/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	2.5% 4/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Cardiac disorders Angina, Stable	4.5% 46/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	6.9% 11/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Cardiac disorders Arrhythmia - Other	4.6% 47/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	6.2% 10/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Cardiac disorders Hypertension	6.2% 64/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	5.6% 9/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Cardiac disorders Hypotension	3.1% 32/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	1.9% 3/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Cardiac disorders Other Cardiovascular	10.7% 110/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	14.4% 23/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Endocrine disorders Diabetes Mellitus, Type II	3.4% 35/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	4.4% 7/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Endocrine disorders Other Endocrine system	3.2% 33/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	1.9% 3/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Gastrointestinal disorders Nausea	3.0% 31/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	1.2% 2/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Gastrointestinal disorders Other Gastrointestinal	11.5% 118/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	6.9% 11/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Infections and infestations Local infection	7.0% 72/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	7.5% 12/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Infections and infestations Other infectious	4.2% 43/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	2.5% 4/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Nervous system disorders Dizziness / vertigo	4.5% 46/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	5.6% 9/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Nervous system disorders Other Neurological / nervous system	8.9% 92/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	8.1% 13/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Respiratory, thoracic and mediastinal disorders Bronchitis	4.5% 46/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	3.1% 5/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Respiratory, thoracic and mediastinal disorders COPD	3.0% 31/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	1.2% 2/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 44/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	3.1% 5/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.2% 53/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	4.4% 7/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Respiratory, thoracic and mediastinal disorders Other respiratory	8.6% 88/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	11.2% 18/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 43/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	2.5% 4/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Musculoskeletal and connective tissue disorders Arthritis	3.7% 38/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	5.0% 8/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Musculoskeletal and connective tissue disorders Back pain	10.9% 112/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	5.0% 8/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Musculoskeletal and connective tissue disorders Fracture (bone)	4.1% 42/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	4.4% 7/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Musculoskeletal and connective tissue disorders Claudication	7.7% 79/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	10.6% 17/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Musculoskeletal and connective tissue disorders Other skeletal, spine and muscular system	26.4% 272/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	21.9% 35/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
General disorders Dissection	2.5% 26/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	3.8% 6/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
General disorders Restenosis	3.0% 31/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	1.9% 3/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Renal and urinary disorders Renal failure / insufficiency	5.5% 57/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	3.1% 5/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
Renal and urinary disorders Urinary infection	7.0% 72/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	5.6% 9/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
General disorders Other Genito-urinary system	5.1% 52/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	8.1% 13/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
General disorders Rash	4.0% 41/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	3.1% 5/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
General disorders Other	38.8% 399/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	41.9% 67/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
General disorders Stenosis	3.9% 40/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	3.1% 5/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.
General disorders Other Vessel Specific	5.3% 55/1029 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.	8.1% 13/160 • Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.