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CompletedNCT01628159Updated Apr 10, 2020Results posted

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

An interventional study of Lutonix Drug Coated Balloon in Peripheral Artery Disease, sponsored by C. R. Bard. Completed at 64 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-10.

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

Phase
Not applicable
Study type
Interventional
Enrollment
657
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

Read the detailed description

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries through 5 years.

02

Conditions studied

  • Peripheral Artery Disease
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 657 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
657 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

Interventions

  • DeviceLutonix Drug Coated Balloon

    balloon angioplasty with a drug coated balloon

    Also known as: Moxy Drug Coated Balloon

06

What researchers measure

Primary outcomes

  1. Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure

    Time frame: 60 months Post Index Procedure

Secondary outcomes

  1. 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

    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.

    Time frame: 1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure

  2. Number of Acute Device Success 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.

    Time frame: At time of Index Procedure

  3. 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

    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).

    Time frame: 30 days post index procedure

  4. 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)

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

  5. Number of Participants With Technical and Procedural Success

    Time frame: At time of index procedure

  6. Number of Participants With Primary Patency of the Target at 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).

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

  7. Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 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.

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

  8. Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure

    Time frame: 1, 6, 12, and 24 months post index procedure

  9. Improvement From Baseline in Rutherford Classification (Index Limb) at 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.

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

  10. Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 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)

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

07

Results

Posted Apr 10, 2020

Participant flow

Participant flow — Overall Study
MilestoneLutonix Drug Coated Balloon
Started657
Completed493
Not completed164

Outcome measures

PrimaryNumber of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure
Time frame:
60 months Post Index Procedure
Reported as:
Number · Events
Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure
EventsLutonix Drug Coated Balloon
Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure0
SecondaryNumber 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

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.

Time frame:
1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure
Reported as:
Count of participants · 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
ParticipantsLutonix Drug Coated Balloon
1 Month Post Index Procedure638
6 months post-index procedure596
12 months post Index procedure525
24 Months Post Index Procedure434
36 Months Post Index Procedure385
48 Months Post Index Procedure347
60 Months Post Index Procedure320
SecondaryNumber of Acute Device Success 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.

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 Balloon
Number of Acute Device Success at Time of Index Procedure894
SecondaryNumber 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

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).

Time frame:
30 days post index procedure
Reported as:
Count of participants · Participants
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
ParticipantsLutonix 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 Procedure642
SecondaryNumber 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)
Time frame:
1, 6, 12, 24, 36, 48, and 60 months post index procedure
Reported as:
Number · 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)
ParticipantsLutonix Drug Coated Balloon
Death : 1 month PPI1
Death : 6 months PPI4
Death : 12 months PPI8
Death : 24 months PPI21
Death : 36 months PPI45
Death : 48 months PPI67
Death : 60 months PPI83
Major Amputation : 1 month PPI0
Major Amputation : 6 months PPI0
Major Amputation : 12 months PPI0
Major Amputation : 24 months PPI1
Major Amputation : 36 months PPI2
Major Amputation : 48 months PPI4
Major Amputation : 60 months PPI6
Minor Amputation : 1 month PPI1
Minor Amputation : 6 months PPI1
Minor Amputation : 12 months PPI1
Minor Amputation : 24 months PPI2
Minor Amputation : 36 months PPI3
Minor Amputation : 48 months PPI6
Minor Amputation : 60 months PPI6
Amputation Free Survival 1 month PPI646
Amputation Free Survival : 6 months PPI632
Amputation Free Survival : 12 months PPI618
Amputation Free Survival : 24 months PPI580
Amputation Free Survival : 36 months PPI547
Amputation Free Survival : 48 months PPI515
Amputation Free Survival : 60 months PPI487
Total TLR : 1 month PPI3
Total TLR : 6 months PPI21
Total TLR : 12 months PPI78
Total TLR : 24 months PPI133
Total TLR : 36 months PPI154
Total TLR : 48 months PPI168
Total TLR : 60 months PPI174
Total TVR : 1 month PPI4
Total TVR : 6 months PPI26
Total TVR : 12 months PPI83
Total TVR : 24 months PPI144
Total TVR : 36 months PPI167
Total TVR : 48 months PPI184
Total TVR : 60 months PPI192
Reintervention Thrombosis1 month PPI0
Reintervention Thrombosis : 6 months PPI0
ReinterventionThrombosis : 12 months PPI1
Reintervention Thrombosis : 24 months PPI3
ReinterventionThrombosis : 36 months PPI4
Reintervention Thrombosis : 48 months PPI4
ReinterventionThrombosis : 60 months PPI5
Cardiovascular Hospitalization : 1 month PPI5
Cardiovascular Hospitalization : 6 months PPI33
Cardiovascular Hospitalization : 12 months PPI57
Cardiovascular Hospitalization : 24 months PPI60
Cardiovascular Hospitalization : 36 months PPI60
Cardiovascular Hospitalization : 48 months PPI60
Cardiovascular Hospitalization : 60 months PPI60
Major Vascular Complication : 1 month PPI12
Major Vascular Complication : 6 months PPI20
Major Vascular Complication : 12 months PPI29
Major Vascular Complication : 24 months PPI47
Major Vascular Complication : 36 months PPI51
Major Vascular Complication : 48 months PPI53
Major Vascular Complication : 60 months PPI54
SecondaryNumber of Participants With Technical and Procedural Success
Time frame:
At time of index procedure
Reported as:
Count of participants · Participants
Number of Participants With Technical and Procedural Success
ParticipantsLutonix Drug Coated Balloon
Technical Success566
Procedural Success565
SecondaryNumber of Participants With Primary Patency of the Target at 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).

Time frame:
6, 12, and 24 months post index procedure
Reported as:
Count of participants · Participants
Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure
ParticipantsLutonix Drug Coated Balloon
6 months post index procedure483
12 months post index procedure386
24 months post index procedure298
SecondaryChange From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 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.

Time frame:
6, 12, and 24 months post index procedure
Reported as:
Mean · Index
Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure
IndexLutonix Drug Coated Balloon
6 months post index procedure0.19 ± 0.27
12 months post index procedure0.18 ± 0.27
At 24 months post index procedure0.16 ± 0.28
SecondaryNumber of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure
Time frame:
1, 6, 12, and 24 months post index procedure
Reported as:
Count of participants · Participants
Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure
ParticipantsLutonix Drug Coated Balloon
1 month post index procedure643
6 months post index procedure611
12 months post index procedure543
24 months post index proceedure456
SecondaryImprovement From Baseline in Rutherford Classification (Index Limb) at 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.

Time frame:
6, 12, and 24 months post index procedure
Reported as:
Count of participants · Participants
Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure
ParticipantsLutonix Drug Coated Balloon
6 months from baseline — Improved540
6 months from baseline — Same49
6 months from baseline — Worsened22
12 months from baseline — Improved498
12 months from baseline — Same62
12 months from baseline — Worsened21
24 months from baseline — Improved459
24 months from baseline — Same57
24 months from baseline — Worsened20
SecondaryNumber of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 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)

Time frame:
6, 12, and 24 months post index procedure
Reported as:
Count of participants · 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
ParticipantsLutonix Drug Coated Balloon
DUS PSVR >= 3.0 : 6 months post index procedure411
DUS PSVR >= 3.0 : 12 months post index procedure295
DUS PSVR >= 3.0 : 24 months post index procdure213
DUS PSVR >= 2.5 : 6 months post index procedure396
DUS PSVR >= 2.5 : 12 months post index procedure289
DUS PSVR >= 2.5 : 24 months post index procdure203
DUS PSVR >= 2.0 : 6 months post index procedure345
DUS PSVR >= 2.0 : 12 months post index procedure242
DUS PSVR >= 2.0 : 24 months post index procdure176

Adverse events

Collected over From Post Index Procedure to End of Follow up Period (5-Year visit window).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lutonix Drug Coated Balloon83/657 (12.6%)67/657 (10.2%)528/657 (80.4%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventLutonix Drug Coated Balloon
Clinically-driven Target Lesion RevascularizationVascular disorders26/657
Target vessel injuryVascular disorders21/657
ClaudicationVascular disorders11/657
Distal embolization with study treatmentVascular disorders3/657
Restenosis of study lesionVascular disorders3/657
Target (study) vessel revascularization (TVR)Vascular disorders2/657
Infection, localInfections and infestations1/657
Infection (systemic)Infections and infestations1/657
Significant hemorrhageGeneral disorders1/657
PseudoaneurysmVascular disorders1/657
Most frequent other events
Showing 10 of 15
Most frequent other events
EventLutonix Drug Coated Balloon
VariousGeneral disorders241/657
Skeletal, spine and muscular events (Other)Musculoskeletal and connective tissue disorders155/657
Gastrointestinal events (other)Gastrointestinal disorders79/657
Other cardiovascular eventsCardiac disorders67/657
Back painMusculoskeletal and connective tissue disorders67/657
ClaudicationMusculoskeletal and connective tissue disorders55/657
Neurological events (other)Nervous system disorders54/657
Local InfectionInfections and infestations52/657
Respiratory (other)Respiratory, thoracic and mediastinal disorders52/657
Urinary infectionRenal and urinary disorders46/657

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Lutonix Drug Coated Balloon
Mean68.7 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Lutonix Drug Coated Balloon
Female238
Male419
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lutonix Drug Coated Balloon
Hispanic or Latino12
Not Hispanic or Latino645
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Lutonix Drug Coated Balloon
United States657
Baseline Rutherford Classification
Baseline Rutherford Classification(Participants)Lutonix Drug Coated Balloon
Rutherford 00
Rutherford 10
Rutherford 2240
Rutherford 3379
Rutherford 438
Rutherford 50
Rutherford 60
08

Study locations

64 sites
  • Good Samaritan Hospital
    Los Angeles, California 90017, United States
  • North County Radiology Medial Group Inc.
    Oceanside, California 92056, United States
  • St. Joseph's Hospital
    Orange, California 92868, United States
  • University of California Davis
    Sacramento, California 95817, United States
  • Medical Center of the Rockies
    Loveland, Colorado 80538, United States
  • Yale New Haven Hospital
    New Haven, Connecticut 06510, United States
  • Washington Cardiology Center
    Washington, District of Columbia 20010, United States
  • Heart and Vascular Institute
    Clearwater, Florida 33756, United States
  • Interventional Cardiolgists of Gainesville
    Gainesville, Florida 32605, United States
  • Munroe Regional Medical Center
    Ocala, Florida 34471, United States
  • Cardiovascular Associates
    Elk Grove Village, Illinois 60007, United States
  • Advocate Christ Medical Center
    Oak Lawn, Illinois 60453, United States
  • Edward Heart / Midwest Research Foundation
    Oakbrook Terrace, Illinois 60181, United States
  • St. John's Hosptial
    Springfield, Illinois 62710, United States
  • Allen County Cardiology
    Fort Wayne, Indiana 46802, United States
  • St. Vincent Heart Center of Indianapolis
    Indianapolis, Indiana 46290, United States
  • Promise Regional Medical Center
    Hutchinson, Kansas 67502, United States
  • St. Francis Heart & Vascular Center
    Topeka, Kansas 66606, United States
  • Massachusetts Genearl Hospital
    Boston, Massachusetts 02114, United States
  • Detroit Medical Center
    Detroit, Michigan 48201, United States
  • St. John's Hospital
    Detroit, Michigan 48236, United States
  • Michigan Heart
    Ypsilanti, Michigan 48197, United States
  • Mercy Hosptial
    Coon Rapids, Minnesota 55433, United States
  • Forrest General Hospital
    Hattiesburg, Mississippi 39401, United States
  • Deborah Heart and Lung Center
    Browns Mills, New Jersey 08015, United States
  • Our Lady of Lourdes Medical Center
    Cherry Hill, New Jersey 08034, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Columbia Universtiy Medical Center
    New York, New York 10032, United States
  • Wake Heart and Vascular
    Raleigh, North Carolina 27610, United States
  • Christ Hospital / The Lindner Clinical Trial Center
    Cincinnati, Ohio 45219, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Mid Ohio Cardiology and Vascular Consultants
    Columbus, Ohio 43214, United States
  • Jobst Vascular Institute
    Toledo, Ohio 43606, United States
  • Univesrity of Toledo Medical Center
    Toledo, Ohio 43614, United States
  • Greenville Memorial Hospital
    Greenville, South Carolina 29615, United States
  • Wellmont Cardiology Services
    Kingsport, Tennessee 37660, United States
  • East Tennessee Heart Consultants
    Knoxville, Tennessee 37934, United States
  • Austin Heart P.A.
    Austin, Texas 78705, United States
  • Medical University of Graz
    Graz, A-8036, Austria
  • Klinikum Klagenfurt
    Klagenfurt, Austria
  • OLV Ziekenhuis
    Aalst, Belgium
  • Imelda Ziekenhuis
    Bonheiden, Belgium
  • Flanders Medical Research Program
    Dendermonde, Belgium
  • Hospital Oost-Limburg
    Genk, Belgium
  • Ghent University Hospital
    Ghent, Belgium
  • Herz-Zentrum
    Bad Krozingen, Germany
  • Jewish Hospital
    Berlin, Germany
  • Universitätsklinikum Carl Gustav Carus
    Dresden, Germany
  • Diakonissenanstalt zu Flensburg
    Flensburg, Germany
  • Hamburg University Cardiovascular Center
    Hamburg, Germany
  • University Clinical Center Heidelberg
    Heidelberg, Germany
  • Herz-Und Gefasszentrum
    Immenstadt, Germany
  • Practice for Interventional Radiology
    Kaiserslautern, Germany
  • Westpfalz Clinic
    Kusen, Germany
  • University Leipzig
    Leipzig, Germany
  • University Magdeburg
    Magdeburg, Germany
  • Universtiy Clinic Muenster
    Muenster, Germany
  • University of Munich
    Munich, Germany
  • Ernst von Bergham Clinic
    Potstdam, Germany
  • University of Tübingen
    Tübingen, Germany
  • University Hospital
    Bern, Switzerland
  • Canton Hospital Lucerne
    Lucerne, Switzerland
  • University Hospital, Zurich
    Zurich, Switzerland
09

References and documents

Publications

  • 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. PubMed 31575518 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 26, 2012

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

Individual participant data

Plan to share: No — Not at this time.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01628159
Lead sponsor
C. R. Bard
Responsible party
Sponsor
First posted
Jun 26, 2012
Start date
Jun 2012
Primary completion
Sep 2018
Completion
Dec 2018
Results posted
Apr 10, 2020
Last update
Apr 10, 2020

Study contacts

Kenneth Rosenfield, MD
principal investigator · Massachusetts General Hospital
Prof. Dierk Scheinert, MD
principal investigator · University Leipzig

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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