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CompletedNCT01790243Updated Jun 5, 2020Results posted

LEVANT 2 Safety Registry

An interventional study of Lutonix Drug Coated Balloon and Standard PTA Balloon in Peripheral Artery Disease, Femoropopliteal Artery Occlusion and Femoropopliteal Stenosis, sponsored by C. R. Bard. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-05.

Sponsored by C. R. Bard · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jul 2011, registered Feb 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
1,189
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.

02

Conditions studied

  • Peripheral Artery Disease
  • Femoropopliteal Artery Occlusion
  • Femoropopliteal Stenosis
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 1,189 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

C. R. Bard is the lead sponsor of 113 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Clinical Inclusion Criteria:

  1. Male or non-pregnant female ≥18 years of age;
  2. Rutherford Clinical Category 2-4;

  3. 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:

  4. Length ≤15 cm;
  5. 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);
  6. ≥70% stenosis by visual estimate;
  7. 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;
  8. De novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
  9. Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
  10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
  11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
  12. 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.
  13. 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);
  14. 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;
  15. 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:

  1. Pregnant or planning on becoming pregnant or men intending to father children;
  2. Life expectancy of \<5 years;
  3. 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.
  4. History of hemorrhagic stroke within 3 months;
  5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
  6. History of MI, thrombolysis or angina within 2 weeks of enrollment;
  7. Rutherford Class 0, 1, 5 or 6;
  8. Renal failure or chronic kidney disease with 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);
  9. 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;
  10. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
  11. Anticipated use of IIb/IIIa inhibitor prior to randomization;
  12. Ipsilateral retrograde access;
  13. Composite lesion length is >15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
  14. Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
  15. 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;
  16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
  17. Severe calcification that renders the lesion un-dilatable;
  18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,189 participants (actual)

Study arms

  • Experimental
    Lutonix Drug Coated Balloon

    Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter

    Device: Lutonix Drug Coated Balloon

  • Active comparator
    Standard Uncoated Angioplasty Balloon

    PTA Catheter

    Device: Standard PTA Balloon

Interventions

  • DeviceLutonix Drug Coated Balloon

    Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.

  • DeviceStandard PTA Balloon

    Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.

    Time frame: From index procedure to 60 months Post Index Procedure

Secondary outcomes

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

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

    Time frame: 30 days post index procedure

  2. 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

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

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

    Time frame: 6, 12, and 24 months post index procedure

  4. 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.

    Time frame: At time of index procedure

  5. 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.

    Time frame: At time of index procedure

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

    Time frame: 6, 12, and 24 months post index procedure

  7. 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.

    Time frame: 6, 12, and 24 months post index procedure

  8. 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.

    Time frame: 6, 12, and 24 months post index procedure

  9. 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.

    Time frame: 6, 12, and 24 months from baseline

07

Results

Posted Jun 5, 2020

Participant flow

Participant flow — Overall Study
MilestoneLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
Started1029160
Completed739117
Not completed29043

Outcome measures

PrimaryNumber of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
Time frame:
From index procedure to 60 months Post Index Procedure
Reported as:
Count of participants · Participants
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
ParticipantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.00
SecondaryNumber of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure

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

Time frame:
30 days post index procedure
Reported as:
Count of participants · Participants
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure
ParticipantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure1002155
SecondaryNumber 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
Time frame:
1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI)
Reported as:
Number · 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
participantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
Death : 1 month post index procedure10
Death : 6 months post index procedure82
Death : 12 months post index procedure184
Death : 24 months post index procedure468
Death : 36 months post index procedure8210
Death : 48 months post index procedure12114
Death : 60 months post index procedure14717
Major Amputation : 1 month post index procedure00
Major Amputation : 6 months post index procedure10
Major Amputation : 12 months post index procedure10
Major Amputation : 24 months post index procedure20
Major Amputation : 36 months post index procedure30
Major Amputation : 48 months post index procedure61
Major Amputation : 60 months post index procedure81
Minor Amputation : 1 month post index procedure10
Minor Amputation : 6 months post index procedure10
Minor Amputation : 12 months post index procedure10
Minor Amputation : 24 months post index procedure30
Minor Amputation : 36 months post index procedure50
Minor Amputation : 48 months post index procedure90
Minor Amputation : 60 months post index procedure90
Amputation Free Survival : 1 month PPI1008156
Amputation Free Survival : 6 months981152
Amputation Free Survival : 12 months PPI949144
Amputation Free Survival : 24 months PPI881133
Amputation Free Survival : 36 months PPI830129
Amputation Free Survival : 48 months PPI776122
Amputation Free Survival : 60 months PPI729115
Target Vessel Revascularization : 1 month PPI61
Target Vessel Revascularization : 6 months PPI4812
Target Vessel Revascularization : 12 months PPI12526
Target Vessel Revascularization : 24 months PPI20739
Target Vessel Revascularization : 36 months PPI24043
Target Vessel Revascularization : 48 months PPI26853
Target Vessel Revascularization : 60 months PPI28354
Reintervention for thrombosis : 1 month20
Reintervention for thrombosis : 6 months21
Reintervention for thrombosis : 12 months31
Reintervention for thrombosis : 24 months51
Reintervention for thrombosis: 36 months71
Reintervention for thrombosis : 48 months71
Reintervention for thrombosis: 60 months81
Cardiovascular Hospitalization : 1 month PPI60
Cardiovascular Hospitalization : 6 months PPI533
Cardiovascular Hospitalization : 12 months PPI8810
Cardiovascular Hospitalization : 24 months PPI11221
Cardiovascular Hospitalization : 36 months PPI11523
Cardiovascular Hospitalization : 48 months PPI11523
Cardiovascular Hospitalization : 60 months PPI11523
Major Vascular Complications : 1 month PPI272
Major Vascular Complications : 6 months PPI394
Major Vascular Complications : 12 months PPI5171
Major Vascular Complications : 24 months PPI7910
Major Vascular Complications : 36 months PPI8713
Major Vascular Complications : 48 months PPI9213
Major Vascular Complications : 60 months PPI9313
SecondaryPercentage of Participants With Primary Patency of the Target Lesion at 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).

Time frame:
6, 12, and 24 months post index procedure
Reported as:
Number · Percentage of Participants
Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure
Percentage of ParticipantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
6 months post index procedure81.4 (78.9 to 84.0)64.8 (56.9 to 72.6)
12 months post index procedure66.3 (63.2 to 69.4)54.0 (45.7 to 62.4)
24 months post index procedure54.5 (51.1 to 57.8)47.2 (38.6 to 55.9)
SecondaryNumber 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.

Time frame:
At time of index procedure
Reported as:
Count of units · Devices
Number of Acute Device Success at Time of Index Procedure
DevicesLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
Number of Acute Device Success at Time of Index Procedure1402180
SecondaryNumber 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.

Time frame:
At time of index procedure
Reported as:
Count of participants · Participants
Number of Participants With Technical and Procedural Success
ParticipantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
Technical Success894138
Procedural Success892138
SecondaryNumber of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure
Time frame:
6, 12, and 24 months post index procedure
Reported as:
Number · participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure
participantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
6 months post index procedure940144
12 months post index procedure839122
24-Months Post-Index Procedure706104
SecondaryNumber 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.

Time frame:
6, 12, and 24 months post index procedure
Reported as:
Count of participants · Participants
Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure
ParticipantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
DUS PSVR >=2.0: 6 months post index procedure56574
DUS PSVR >=2.0: 12 months post index procedure40062
DUS PSVR >=2.0: 24 months post index procedure28238
DUS PSVR >=3.0: 6 months post index procedure67098
DUS PSVR >=3.0: 12 months post index procedure49273
DUS PSVR >=3.0: 24 months post index procedure34448
SecondaryImprovement 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.

Time frame:
6, 12, and 24 months post index procedure
Reported as:
Count of participants · Participants
Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline
ParticipantsLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
6 months from baseline — Improved830118
6 months from baseline — Same7922
6 months from baseline — Worsened355
12 months from baseline — Improved771108
12 months from baseline — Same8921
12 months from baseline — Worsened302
24 months from baseline — Improved701106
24 months from baseline — Same8815
24 months from baseline — Worsened271
SecondaryChange 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.

Time frame:
6, 12, and 24 months from baseline
Reported as:
Mean · Ratio
Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline
RatioLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
6 months post index procedure0.19 ± 0.260.16 ± 0.22
12 months post index procedure0.18 ± 0.260.18 ± 0.25
24-Months Post-Index Procedure0.16 ± 0.270.17 ± 0.24

Adverse events

Collected over Adverse events (AEs) and Serious Adverse Events (SAEs) collected by all sites from the time of index procedure to 60 months follow up.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lutonix Drug Coated Balloon147/1,029 (14.3%)813/1,029 (79%)845/1,029 (82.1%)
Standard Uncoated Angioplasty Balloon17/160 (10.6%)125/160 (78.1%)126/160 (78.8%)
Most frequent serious events
Showing 10 of 126
Most frequent serious events
EventLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
OtherGeneral disorders163/102921/160
Other CardiovascularVascular disorders152/102920/160
StenosisGeneral disorders126/102923/160
RestenosisGeneral disorders112/102922/160
RestenosisGeneral disorders65/102918/160
Myocardial infarctionVascular disorders69/102917/160
Other Skeletal, spine and muscular systemMusculoskeletal and connective tissue disorders89/102912/160
PneumoniaRespiratory, thoracic and mediastinal disorders75/10297/160
Other GastrointestinalGastrointestinal disorders68/102911/160
AtherosclerosisGeneral disorders36/102911/160
Most frequent other events
Showing 10 of 35
Most frequent other events
EventLutonix Drug Coated BalloonStandard Uncoated Angioplasty Balloon
OtherGeneral disorders399/102967/160
Other skeletal, spine and muscular systemMusculoskeletal and connective tissue disorders272/102935/160
Other CardiovascularCardiac disorders110/102923/160
Other GastrointestinalGastrointestinal disorders118/102911/160
Other respiratoryRespiratory, thoracic and mediastinal disorders88/102918/160
Back painMusculoskeletal and connective tissue disorders112/10298/160
ClaudicationMusculoskeletal and connective tissue disorders79/102917/160
Other Neurological / nervous systemNervous system disorders92/102913/160
Other Genito-urinary systemGeneral disorders52/102913/160
Other Vessel SpecificGeneral disorders55/102913/160

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Lutonix Drug Coated BalloonStandard Uncoated Angioplasty BalloonTotal
Mean68.4 ± 9.769.0 ± 968.48 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Lutonix Drug Coated BalloonStandard Uncoated Angioplasty BalloonTotal
Female38353436
Male646107753
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lutonix Drug Coated BalloonStandard Uncoated Angioplasty BalloonTotal
Hispanic or Latino391453
Not Hispanic or Latino9881461134
Unknown or Not Reported202
Baseline Rutherford Classification
Baseline Rutherford Classification(Participants)Lutonix Drug Coated BalloonStandard Uncoated Angioplasty BalloonTotal
Rutherford 0000
Rutherford 1000
Rutherford 235455409
Rutherford 360692698
Rutherford 4691382
Rutherford 5000
Rutherford 6000
08

Study locations

8 sites
  • Mission Cardiovascular Research Institute
    Fremont, California 94538, United States
  • Metro Health Hospital
    Wyoming, Michigan 49519, United States
  • Jackson Heart Clinic/St. Dominic's Hospital
    Jackson, Mississippi 39216, United States
  • Mercy Hospital
    Springfield, Missouri 65804, United States
  • Holy Name Medical Center
    Teaneck, New Jersey 07666, United States
  • New York Presbyterian Hospital/Weill Cornell Medical Center
    New York, New York 10021, United States
  • TriHealth Heart Institute
    Cincinnati, Ohio 45220, United States
  • Mission Research Institute
    New Braunfels, Texas 78130, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 7, 2012

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01790243
Lead sponsor
C. R. Bard
Responsible party
Sponsor
First posted
Feb 13, 2013
Start date
Jul 20, 2011
Primary completion
Nov 27, 2015
Completion
Nov 1, 2018
Results posted
Jun 5, 2020
Last update
Jun 5, 2020

Study contacts

Kenneth Rosenfield, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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