Trial Outcomes & Findings for LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB) (NCT NCT01628159)

NCT ID: NCT01628159

Last Updated: 2020-04-10

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

657 participants

Primary outcome timeframe

60 months Post Index Procedure

Results posted on

2020-04-10

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: balloon angioplasty with a drug coated balloon
Overall Study STARTED	657
Overall Study COMPLETED	493
Overall Study NOT COMPLETED	164

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Age, Continuous	68.7 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	238 Participants n=5 Participants
Sex: Female, Male Male	419 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	645 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	657 participants n=5 Participants
Baseline Rutherford Classification Rutherford 0	0 Participants n=5 Participants
Baseline Rutherford Classification Rutherford 1	0 Participants n=5 Participants
Baseline Rutherford Classification Rutherford 2	240 Participants n=5 Participants
Baseline Rutherford Classification Rutherford 3	379 Participants n=5 Participants
Baseline Rutherford Classification Rutherford 4	38 Participants n=5 Participants
Baseline Rutherford Classification Rutherford 5	0 Participants n=5 Participants
Baseline Rutherford Classification Rutherford 6	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 months Post Index Procedure

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure	0 Events

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.

Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death.

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 1 Month Post Index Procedure	638 Participants
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 6 months post-index procedure	596 Participants
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 12 months post Index procedure	525 Participants
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 24 Months Post Index Procedure	434 Participants
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 36 Months Post Index Procedure	385 Participants
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 48 Months Post Index Procedure	347 Participants
Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 60 Months Post Index Procedure	320 Participants

SECONDARY outcome

Timeframe: At time of Index Procedure

In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint.

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=894 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: balloon angioplasty with a drug coated balloon
Number of Acute Device Success at Time of Index Procedure	894 Devices

SECONDARY outcome

Timeframe: 30 days post index procedure

This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR).

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=647 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: balloon angioplasty with a drug coated balloon
Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure	642 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Number of Participants With Freedom From 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 (PPI) Minor Amputation : 60 months PPI	6 Participants
Number of Participants With Freedom From 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 (PPI) Amputation Free Survival 1 month PPI	646 Participants
Number of Participants With Freedom From 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 (PPI) Total TLR : 1 month PPI	3 Participants
Number of Participants With Freedom From 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 (PPI) Total TLR : 6 months PPI	21 Participants
Number of Participants With Freedom From 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 (PPI) Total TLR : 12 months PPI	78 Participants
Number of Participants With Freedom From 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 (PPI) Total TLR : 24 months PPI	133 Participants
Number of Participants With Freedom From 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 (PPI) Cardiovascular Hospitalization : 6 months PPI	33 Participants
Number of Participants With Freedom From 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 (PPI) Cardiovascular Hospitalization : 12 months PPI	57 Participants
Number of Participants With Freedom From 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 (PPI) Major Vascular Complication : 48 months PPI	53 Participants
Number of Participants With Freedom From 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 (PPI) Major Vascular Complication : 60 months PPI	54 Participants
Number of Participants With Freedom From 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 (PPI) Death : 1 month PPI	1 Participants
Number of Participants With Freedom From 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 (PPI) Death : 6 months PPI	4 Participants
Number of Participants With Freedom From 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 (PPI) Death : 12 months PPI	8 Participants
Number of Participants With Freedom From 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 (PPI) Death : 24 months PPI	21 Participants
Number of Participants With Freedom From 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 (PPI) Death : 36 months PPI	45 Participants
Number of Participants With Freedom From 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 (PPI) Death : 48 months PPI	67 Participants
Number of Participants With Freedom From 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 (PPI) Death : 60 months PPI	83 Participants
Number of Participants With Freedom From 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 (PPI) Major Amputation : 1 month PPI	0 Participants
Number of Participants With Freedom From 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 (PPI) Major Amputation : 6 months PPI	0 Participants
Number of Participants With Freedom From 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 (PPI) Major Amputation : 12 months PPI	0 Participants
Number of Participants With Freedom From 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 (PPI) Major Amputation : 24 months PPI	1 Participants
Number of Participants With Freedom From 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 (PPI) Major Amputation : 36 months PPI	2 Participants
Number of Participants With Freedom From 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 (PPI) Major Amputation : 48 months PPI	4 Participants
Number of Participants With Freedom From 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 (PPI) Major Amputation : 60 months PPI	6 Participants
Number of Participants With Freedom From 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 (PPI) Minor Amputation : 1 month PPI	1 Participants
Number of Participants With Freedom From 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 (PPI) Minor Amputation : 6 months PPI	1 Participants
Number of Participants With Freedom From 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 (PPI) Minor Amputation : 12 months PPI	1 Participants
Number of Participants With Freedom From 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 (PPI) Minor Amputation : 24 months PPI	2 Participants
Number of Participants With Freedom From 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 (PPI) Minor Amputation : 36 months PPI	3 Participants
Number of Participants With Freedom From 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 (PPI) Minor Amputation : 48 months PPI	6 Participants
Number of Participants With Freedom From 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 (PPI) Amputation Free Survival : 6 months PPI	632 Participants
Number of Participants With Freedom From 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 (PPI) Amputation Free Survival : 12 months PPI	618 Participants
Number of Participants With Freedom From 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 (PPI) Amputation Free Survival : 24 months PPI	580 Participants
Number of Participants With Freedom From 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 (PPI) Amputation Free Survival : 36 months PPI	547 Participants
Number of Participants With Freedom From 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 (PPI) Amputation Free Survival : 48 months PPI	515 Participants
Number of Participants With Freedom From 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 (PPI) Amputation Free Survival : 60 months PPI	487 Participants
Number of Participants With Freedom From 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 (PPI) Total TLR : 36 months PPI	154 Participants
Number of Participants With Freedom From 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 (PPI) Total TLR : 48 months PPI	168 Participants
Number of Participants With Freedom From 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 (PPI) Total TLR : 60 months PPI	174 Participants
Number of Participants With Freedom From 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 (PPI) Total TVR : 1 month PPI	4 Participants
Number of Participants With Freedom From 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 (PPI) Total TVR : 6 months PPI	26 Participants
Number of Participants With Freedom From 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 (PPI) Total TVR : 12 months PPI	83 Participants
Number of Participants With Freedom From 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 (PPI) Total TVR : 24 months PPI	144 Participants
Number of Participants With Freedom From 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 (PPI) Total TVR : 36 months PPI	167 Participants
Number of Participants With Freedom From 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 (PPI) Total TVR : 48 months PPI	184 Participants
Number of Participants With Freedom From 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 (PPI) Total TVR : 60 months PPI	192 Participants
Number of Participants With Freedom From 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 (PPI) Reintervention Thrombosis1 month PPI	0 Participants
Number of Participants With Freedom From 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 (PPI) Reintervention Thrombosis : 6 months PPI	0 Participants
Number of Participants With Freedom From 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 (PPI) ReinterventionThrombosis : 12 months PPI	1 Participants
Number of Participants With Freedom From 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 (PPI) Reintervention Thrombosis : 24 months PPI	3 Participants
Number of Participants With Freedom From 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 (PPI) ReinterventionThrombosis : 36 months PPI	4 Participants
Number of Participants With Freedom From 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 (PPI) Reintervention Thrombosis : 48 months PPI	4 Participants
Number of Participants With Freedom From 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 (PPI) ReinterventionThrombosis : 60 months PPI	5 Participants
Number of Participants With Freedom From 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 (PPI) Cardiovascular Hospitalization : 1 month PPI	5 Participants
Number of Participants With Freedom From 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 (PPI) Cardiovascular Hospitalization : 24 months PPI	60 Participants
Number of Participants With Freedom From 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 (PPI) Cardiovascular Hospitalization : 36 months PPI	60 Participants
Number of Participants With Freedom From 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 (PPI) Cardiovascular Hospitalization : 48 months PPI	60 Participants
Number of Participants With Freedom From 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 (PPI) Cardiovascular Hospitalization : 60 months PPI	60 Participants
Number of Participants With Freedom From 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 (PPI) Major Vascular Complication : 1 month PPI	12 Participants
Number of Participants With Freedom From 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 (PPI) Major Vascular Complication : 6 months PPI	20 Participants
Number of Participants With Freedom From 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 (PPI) Major Vascular Complication : 12 months PPI	29 Participants
Number of Participants With Freedom From 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 (PPI) Major Vascular Complication : 24 months PPI	47 Participants
Number of Participants With Freedom From 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 (PPI) Major Vascular Complication : 36 months PPI	51 Participants

SECONDARY outcome

Timeframe: At time of index procedure

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Number of Participants With Technical and Procedural Success Technical Success	566 Participants
Number of Participants With Technical and Procedural Success Procedural Success	565 Participants

SECONDARY outcome

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

Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS ≥ 2.5) and target lesion revascularization (TLR).

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	483 Participants
Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	386 Participants
Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure 24 months post index procedure	298 Participants

SECONDARY outcome

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

Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The 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. A lower ABI number suggests more Peripheral Arterial Disease.

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure At 24 months post index procedure	0.16 Index Standard Deviation 0.28
Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	0.19 Index Standard Deviation 0.27
Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	0.18 Index Standard Deviation 0.27

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure 1 month post index procedure	643 Participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure 6 months post index procedure	611 Participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure 12 months post index procedure	543 Participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure 24 months post index proceedure	456 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=657 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: balloon angioplasty with a drug coated balloon
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 6 months from baseline · Improved	540 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 6 months from baseline · Same	49 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 6 months from baseline · Worsened	22 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 12 months from baseline · Improved	498 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 12 months from baseline · Same	62 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 12 months from baseline · Worsened	21 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 24 months from baseline · Improved	459 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 24 months from baseline · Same	57 Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure 24 months from baseline · Worsened	20 Participants

SECONDARY outcome

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

* Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) \<2.0 and \<3.0 * Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) \<2.5 without prior Clinically Driven TLR)

Outcome measures

Outcome measures
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 3.0 : 6 months post index procedure	411 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 3.0 : 12 months post index procedure	295 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 3.0 : 24 months post index procdure	213 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 2.5 : 6 months post index procedure	396 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 2.5 : 12 months post index procedure	289 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 2.5 : 24 months post index procdure	203 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 2.0 : 6 months post index procedure	345 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 2.0 : 12 months post index procedure	242 Participants
Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure DUS PSVR >= 2.0 : 24 months post index procdure	176 Participants

Adverse Events

Lutonix Drug Coated Balloon

Serious events: 67 serious events

Other events: 528 other events

Deaths: 83 deaths

Serious adverse events

Serious adverse events
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Vascular disorders Distal embolization with study treatment	0.46% 3/657 • Number of events 3 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Infections and infestations Infection, local	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Infections and infestations Infection (systemic)	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
General disorders Significant hemorrhage	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Pseudoaneurysm	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Target vessel injury	3.2% 21/657 • Number of events 21 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Distal embolization with post treatment	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Clot/Thrombus formation	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Other angiographic event	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Restenosis of study lesion	0.46% 3/657 • Number of events 3 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Clinically-driven Target Lesion Revascularization	4.0% 26/657 • Number of events 26 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Target (study) vessel revascularization (TVR)	0.30% 2/657 • Number of events 2 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Target (study) limb ishchemia	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Other vascular event	0.15% 1/657 • Number of events 1 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Claudication	1.7% 11/657 • Number of events 11 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.

Other adverse events

Other adverse events
Measure	Lutonix Drug Coated Balloon n=657 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: balloon angioplasty with a drug coated balloon
Cardiac disorders Arrhytmia	5.2% 34/657 • Number of events 36 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Cardiac disorders Hypertension	6.5% 43/657 • Number of events 50 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Cardiac disorders Other cardiovascular events	10.2% 67/657 • Number of events 87 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Gastrointestinal disorders Gastrointestinal events (other)	12.0% 79/657 • Number of events 128 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Infections and infestations Local Infection	7.9% 52/657 • Number of events 69 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Nervous system disorders Neurological events (other)	8.2% 54/657 • Number of events 64 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Respiratory, thoracic and mediastinal disorders Respiratory (other)	7.9% 52/657 • Number of events 67 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Musculoskeletal and connective tissue disorders Back pain	10.2% 67/657 • Number of events 72 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Musculoskeletal and connective tissue disorders Claudication	8.4% 55/657 • Number of events 59 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Musculoskeletal and connective tissue disorders Skeletal, spine and muscular events (Other)	23.6% 155/657 • Number of events 241 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Vascular disorders Restenosis	5.3% 35/657 • Number of events 36 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Renal and urinary disorders Renal failure/ insufficiency	5.3% 35/657 • Number of events 37 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Renal and urinary disorders Urinary infection	7.0% 46/657 • Number of events 65 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
General disorders Various	36.7% 241/657 • Number of events 527 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
General disorders Vessel specific events (Other)	6.2% 41/657 • Number of events 44 • From Post Index Procedure to End of Follow up Period (5-Year visit window). All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.

Additional Information

Director of Clinical Affairs

Phone: 763-445-2385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place