Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty... | NCT01412541

Status Module

Label	Type	Description	Intervention Names
Moxy Drug Coated Balloon	Experimental	Paclitaxel coated balloon catheter	Device: Moxy Drug Coated Balloon
Standard Uncoated Angioplasty Balloon	Active Comparator	PTA Catheter	Procedure: Standard Uncoated Angioplasty Balloon

Name	Type	Description	Arm Group Labels	Other Names
Standard Uncoated Angioplasty Balloon	Procedure	Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon	Standard Uncoated Angioplasty Balloon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure	Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.	12 months post index procedure
Percentage of Participants With Primary Patency of the Target Lesion at 12 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).	12 months post index procedure

Secondary Outcomes

Measure	Description	Time Frame
Number of Acute Device Success 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.	At time of Index Procedure

Eligibility Module

Eligibility Criteria

Clinical Inclusion Criteria:

Male or non-pregnant female ≥18 years of age;
Rutherford Clinical Category 2-4;
Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;

Angiographic Lesion Inclusion Criteria:
Length ≤15 cm;
Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of ≤15 cm);
≥70% stenosis by visual estimate;
Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
de novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.

Exclusion Criteria:

Patients will be excluded if ANY of the following conditions apply:

Pregnant or planning on becoming pregnant or men intending to father children;
Life expectancy of <5 years;
Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
History of hemorrhagic stroke within 3 months;
Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of enrollment;
Rutherford Class 0, 1, 5 or 6;
Renal failure or chronic kidney disease with modification in diet in renal disease glomerular filtration rate (MDRD GFR) ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
Anticipated use of IIb/IIIa inhibitor prior to randomization;
Ipsilateral retrograde access;
Composite lesion length is >15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
Severe calcification that renders the lesion un-dilatable;
Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).

Name	Affiliation	Role
Kenneth Rosenfield, MD	Massachusetts General Hospital	Principal Investigator
Prof. Dierk Scheinert	University Leipzig	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Good Samaritan Hospital		Los Angeles	California	90017	United States
North County Radiology Medial Group Inc.

PubMed Identifier	Type	Citation	Retractions
31575518	Derived	Ouriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28.
27117972	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
FG001	Standard Uncoated Angioplasty Balloon

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 26, 2012

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure

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

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.

Posted

Number

95% Confidence Interval

Percentage of participants

12 months post index procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants	OG000335 OG001146

Title

Denominators

Categories

Title	Measurements
	OG00085.4(81.6 to 89.2) OG00179.5(72.9 to 86.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	To assess if proportion of subjects with at least one safety event* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group. H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group.	Farrington and Manning		0.025														Non-Inferiority or Equivalence (legacy)	The evaluable sample size required for 90% power is 150 (50 Control plus 100 Test). This endpoint is not the sample-size driver of the study. Randomization of 476 subjects is expected to provide at least 405 evaluable subjects, after adjustment for up to 15% censoring) and approximately 99% power.

Primary

Percentage of Participants With Primary Patency of the Target Lesion at 12 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).

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.

Posted

Number

95% Confidence Interval

Percentage of participants

12 months post index procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Number of Acute Device Success 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.

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.

Posted

Count of Units

Devices

At time of Index Procedure

Devices

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Number of Participants With Technical and Procedural Success

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.

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.

Posted

Count of Participants

Participants

At time of Index Procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units

Secondary

Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure

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

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.

Posted

Count of Participants

Participants

6, 12, and 24 months post index procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Number of Participants With Alternative Primary Patency at 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.

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.

Posted

Count of Participants

Participants

6, 12, and 24 months post index procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Secondary

Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure

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

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.

Posted

Number

Participants

6, 12, and 24 months post index porcedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure

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.

Posted

Number

Participants

6, 12, and 24 months post index procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants	OG000

Secondary

Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline

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.

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.

Posted

Count of Participants

Participants

6, 12, and 24 months post index procedure

ID	Title	Description
OG000	Moxy Drug Coated Balloon	Paclitaxel coated balloon catheter Moxy Drug Coated Balloon: Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon
OG001	Standard Uncoated Angioplasty Balloon	PTA Catheter Standard Uncoated Angioplasty Balloon: Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon

Units	Counts
Participants

Secondary

Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to 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.

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.

Posted

Mean

Standard Deviation

Index

6, 12, and 24 months from baseline

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline

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

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.

Posted

Mean

Standard Deviation

Meters

6, 12, and 24 months from baseline

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline.

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

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.

Posted

Mean

Standard Deviation

Score on a scale

6, 12, and 24 months

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Secondary

Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline.

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

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.

Posted

Mean

Standard Deviation

score on a scale

6, 12, and 24 months

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Secondary

Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline

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

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.

Posted

Mean

Standard Deviation

score on a scale

6, 12, and 24 months from baseline

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Secondary

Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Porcedure

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

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.

Posted

Count of Participants

Participants

30 days post index procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death

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.

Posted

Number

Participants

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

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI.

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

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.

Posted

Number

participants

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

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Units	Counts
Participants

Secondary

Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline.

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

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.

Posted

Mean

Standard Deviation

score on a scale

6, 12, and 24 months post index procedure

ID	Title	Description
OG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
OG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina, stable	Cardiac disorders	Internal system	Systematic Assessment	EG00028 affected372 at risk EG0018 affected160 at risk
Angina, Unstable	Cardiac disorders	Internal system	Systematic Assessment	EG00010 affected372 at risk EG0015 affected160 at risk
Arrhytmia, Other	Cardiac disorders	Internal system	Systematic Assessment	EG00014 affected372 at risk EG00110 affected160 at risk
Chronic heart failure	Cardiac disorders	Internal system	Systematic Assessment	EG00018 affected372 at risk EG0018 affected160 at risk
Hypertension	Cardiac disorders	Internal system	Systematic Assessment	EG00010 affected372 at risk EG00110 affected160 at risk
Myocardial infarction	Cardiac disorders	Internal system	Systematic Assessment	EG00024 affected372 at risk EG00117 affected160 at risk
Cardiovascular, Other	Cardiac disorders	Internal system	Systematic Assessment	EG00059 affected372 at risk EG00120 affected160 at risk
Diarrhea	Gastrointestinal disorders	Internal system	Systematic Assessment	EG0002 affected372 at risk EG0016 affected160 at risk
Gastrointestinal bleeding	Gastrointestinal disorders	Internal system	Systematic Assessment	EG00020 affected372 at risk EG0018 affected160 at risk
Gastrointestinal, Others	Gastrointestinal disorders	Internal system	Systematic Assessment	EG00022 affected372 at risk EG00111 affected160 at risk
Local infection	Infections and infestations	Internal system	Systematic Assessment	EG0008 affected372 at risk EG0018 affected160 at risk
Stroke -ischemic	Nervous system disorders	Internal system	Systematic Assessment	EG00015 affected372 at risk EG0013 affected160 at risk
Other neurological - nervous system	Nervous system disorders	Internal system	Systematic Assessment	EG00015 affected372 at risk EG0017 affected160 at risk
Carcinoma	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00012 affected372 at risk EG0013 affected160 at risk
Other respiratory	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00021 affected372 at risk EG0016 affected160 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00032 affected372 at risk EG0017 affected160 at risk
Fracture (bone)	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG00013 affected372 at risk EG00110 affected160 at risk
Claudication	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG0003 affected372 at risk EG0016 affected160 at risk
Other skeletal, spine and muscular system	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG00032 affected372 at risk EG00112 affected160 at risk
Restenosis	Vascular disorders	Internal system	Systematic Assessment	EG00065 affected372 at risk EG00133 affected160 at risk
Occlusion/closure	Vascular disorders	Internal system	Systematic Assessment	EG0006 affected372 at risk EG0015 affected160 at risk
Restenosis	Vascular disorders	Internal system	Systematic Assessment	EG00019 affected372 at risk EG00118 affected160 at risk
Renal failure/ insufficiency	Renal and urinary disorders	Internal system	Systematic Assessment	EG00020 affected372 at risk EG0019 affected160 at risk
Urinary infection	Renal and urinary disorders	Internal system	Systematic Assessment	EG0008 affected372 at risk EG0015 affected160 at risk
Other genito-urinary system	Renal and urinary disorders	Internal system	Systematic Assessment	EG00010 affected372 at risk EG0015 affected160 at risk
Carcinoma	General disorders	Internal system	Systematic Assessment	EG00026 affected372 at risk EG0015 affected160 at risk
Other	General disorders	Internal system	Systematic Assessment	EG00065 affected372 at risk EG00121 affected160 at risk
Arterial occlusion	Vascular disorders	Internal system	Systematic Assessment	EG00012 affected372 at risk EG0019 affected160 at risk
Atherosclerosis	Vascular disorders	Internal system	Systematic Assessment	EG00015 affected372 at risk EG00111 affected160 at risk
Restenosis	Vascular disorders	Internal system	Systematic Assessment	EG00032 affected372 at risk EG00122 affected160 at risk
Stenosis	Vascular disorders	Internal system	Systematic Assessment	EG00042 affected372 at risk EG00123 affected160 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hematoma bleeding puncture site minor	General disorders	Internal system	Systematic Assessment	EG00023 affected372 at risk EG0014 affected160 at risk
Angina, Stable	Vascular disorders	Internal system	Systematic Assessment	EG00023 affected372 at risk EG00111 affected160 at risk
Angina, Unstable	Vascular disorders	Internal system	Systematic Assessment	EG00012 affected372 at risk EG0012 affected160 at risk
Arrythmia - other	Cardiac disorders	Internal system	Systematic Assessment	EG00013 affected372 at risk EG00110 affected160 at risk
Hypertension	Vascular disorders	Internal system	Systematic Assessment	EG00021 affected372 at risk EG0019 affected160 at risk
Hypotension	Vascular disorders	Internal system	Systematic Assessment	EG00013 affected372 at risk EG0013 affected160 at risk
Other - Cardiovascular	Vascular disorders	Internal system	Systematic Assessment	EG00043 affected372 at risk EG00123 affected160 at risk
Diabetes Melitus Type II	Endocrine disorders	Internal system	Systematic Assessment	EG00012 affected372 at risk EG0017 affected160 at risk
Nausea	Gastrointestinal disorders	Internal system	Systematic Assessment	EG00013 affected372 at risk EG0012 affected160 at risk
Other- gastrointestinal	Gastrointestinal disorders	Internal system	Systematic Assessment	EG00039 affected372 at risk EG00111 affected160 at risk
Infection, local	Infections and infestations	Internal system	Systematic Assessment	EG00020 affected372 at risk EG00112 affected160 at risk
Other infectious	Infections and infestations	Internal system	Systematic Assessment	EG00012 affected372 at risk EG0014 affected160 at risk
Dizziness/ vertigo	Nervous system disorders	Internal system	Systematic Assessment	EG00019 affected372 at risk EG0019 affected160 at risk
Other neurological/ nervous system	Nervous system disorders	Internal system	Systematic Assessment	EG00038 affected372 at risk EG00113 affected160 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00022 affected372 at risk EG0015 affected160 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00017 affected372 at risk EG0015 affected160 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00024 affected372 at risk EG0017 affected160 at risk
Other respiratory	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00036 affected372 at risk EG00118 affected160 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Internal system	Systematic Assessment	EG00016 affected372 at risk EG0014 affected160 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG00016 affected372 at risk EG0014 affected160 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG00014 affected372 at risk EG0018 affected160 at risk
Back pain	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG00045 affected372 at risk EG0018 affected160 at risk
Fracture (bone)	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG00017 affected372 at risk EG0017 affected160 at risk
Claudication	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG00024 affected372 at risk EG00117 affected160 at risk
Other skeletal, spine and muscular system	Musculoskeletal and connective tissue disorders	Internal system	Systematic Assessment	EG000117 affected372 at risk EG00135 affected160 at risk
Dissection	General disorders	Internal system	Systematic Assessment	EG00011 affected372 at risk EG0016 affected160 at risk
Restenosis	Vascular disorders	Internal system	Systematic Assessment	EG00018 affected372 at risk EG00111 affected160 at risk
Restenosis in target vessel	Vascular disorders	Internal system	Systematic Assessment	EG00014 affected372 at risk EG0013 affected160 at risk
Renal failure/ insufficiency	Renal and urinary disorders	Internal system	Systematic Assessment	EG00022 affected372 at risk EG0015 affected160 at risk
Urinary infection	Renal and urinary disorders	Internal system	Systematic Assessment	EG00026 affected372 at risk EG0019 affected160 at risk
Other, genito-urinary system	Renal and urinary disorders	Internal system	Systematic Assessment	EG00024 affected372 at risk EG00113 affected160 at risk
Rash	Skin and subcutaneous tissue disorders	Internal system	Systematic Assessment	EG00012 affected372 at risk EG0015 affected160 at risk
Other	General disorders	Internal system	Systematic Assessment	EG000157 affected372 at risk EG00167 affected160 at risk
Restenosis	Vascular disorders	Internal system	Systematic Assessment	EG00013 affected372 at risk EG0013 affected160 at risk
Stenosis	Vascular disorders	Internal system	Systematic Assessment	EG00015 affected372 at risk EG0015 affected160 at risk
Other vessel specific	Vascular disorders	Internal system	Systematic Assessment	EG00014 affected372 at risk EG0013 affected160 at risk

ID	Term
D012208	Rhabdomyosarcoma
D009217	Myosarcoma
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D012509	Sarcoma

ID	Title	Description
BG000	Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
BG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lutonix 035 Drug Coated Balloon (Lutonix DCB)	Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	64	372	289	372	316	372
EG001	Standard Uncoated Angioplasty Balloon	Control group: standard uncoated PTA catheter Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon.	17	160	125	160	126	160