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Peripheral Artery DiseaseNCT01628159

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

A study testing Lutonix Drug Coated Balloon in people with Peripheral Artery Disease, run by C. R. Bard at 64 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Lutonix Drug Coated Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
657 participants
Where
64 sitesin 5 countries
Study dates
Jun 2012to Dec 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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;
Show all 19Show fewer
  • History of MI, thrombolysis or angina within 2 weeks of enrollment;
  • Rutherford Class 0, 1, 5 or 6;
  • 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);
  • 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.).

Trial locations and contacts

64 sites in 5 countries.

64 sites in 5 countries

United States39 sites

  • Austin Heart P.A.

    Austin, Texas, 78705

  • Massachusetts Genearl Hospital

    Boston, Massachusetts, 02114

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Our Lady of Lourdes Medical Center

    Cherry Hill, New Jersey, 08034

  • Christ Hospital / The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Heart and Vascular Institute

    Clearwater, Florida, 33756

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Mid Ohio Cardiology and Vascular Consultants

    Columbus, Ohio, 43214

  • Mercy Hosptial

    Coon Rapids, Minnesota, 55433

  • Detroit Medical Center

    Detroit, Michigan, 48201

  • St. John's Hospital

    Detroit, Michigan, 48236

  • Cardiovascular Associates

    Elk Grove Village, Illinois, 60007

  • Allen County Cardiology

    Fort Wayne, Indiana, 46802

  • Interventional Cardiolgists of Gainesville

    Gainesville, Florida, 32605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29615

  • Forrest General Hospital

    Hattiesburg, Mississippi, 39401

  • Promise Regional Medical Center

    Hutchinson, Kansas, 67502

  • St. Vincent Heart Center of Indianapolis

    Indianapolis, Indiana, 46290

  • Wellmont Cardiology Services

    Kingsport, Tennessee, 37660

  • East Tennessee Heart Consultants

    Knoxville, Tennessee, 37934

  • Good Samaritan Hospital

    Los Angeles, California, 90017

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia Universtiy Medical Center

    New York, New York, 10032

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Edward Heart / Midwest Research Foundation

    Oakbrook Terrace, Illinois, 60181

  • Munroe Regional Medical Center

    Ocala, Florida, 34471

  • North County Radiology Medial Group Inc.

    Oceanside, California, 92056

  • St. Joseph's Hospital

    Orange, California, 92868

  • Wake Heart and Vascular

    Raleigh, North Carolina, 27610

  • University of California Davis

    Sacramento, California, 95817

  • St. John's Hosptial

    Springfield, Illinois, 62710

  • Jobst Vascular Institute

    Toledo, Ohio, 43606

  • Univesrity of Toledo Medical Center

    Toledo, Ohio, 43614

  • St. Francis Heart & Vascular Center

    Topeka, Kansas, 66606

  • Washington Cardiology Center

    Washington D.C., District of Columbia, 20010

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany15 sites

  • Herz-Zentrum

    Bad Krozingen

  • Jewish Hospital

    Berlin

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Diakonissenanstalt zu Flensburg

    Flensburg

  • Hamburg University Cardiovascular Center

    Hamburg

  • University Clinical Center Heidelberg

    Heidelberg

  • Herz-Und Gefasszentrum

    Immenstadt im Allgäu

  • Practice for Interventional Radiology

    Kaiserslautern

  • Westpfalz Clinic

    Kusen

  • University Leipzig

    Leipzig

  • University Magdeburg

    Magdeburg

  • University of Munich

    Munich

  • Universtiy Clinic Muenster

    Münster

  • Ernst von Bergham Clinic

    Potstdam

  • University of Tübingen

    Tübingen

Other trials in Germany

Belgium5 sites

  • OLV Ziekenhuis

    Aalst

  • Imelda Ziekenhuis

    Bonheiden

  • Flanders Medical Research Program

    Dendermonde

  • Hospital Oost-Limburg

    Genk

  • Ghent University Hospital

    Ghent

Other trials in Belgium

Switzerland3 sites

  • University Hospital

    Bern

  • Canton Hospital Lucerne

    Lucerne

  • University Hospital, Zurich

    Zurich

Other trials in Switzerland

Austria2 sites

  • Medical University of Graz

    Graz, A-8036

  • Klinikum Klagenfurt

    Klagenfurt

Other trials in Austria

About this study

Official title: A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries

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.

Being tested
Lutonix Drug Coated Balloon
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutonix Drug Coated BalloonDevice

    Also called Moxy Drug Coated Balloon

    balloon angioplasty with a drug coated balloon

Study groups in NCT01628159
Study groupRoleWhat they receive
Lutonix Drug Coated BalloonExperimentalFormerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter
Receives: Device: Lutonix Drug Coated Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 60 months Post Index Procedure

Secondary outcomes (10)

  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.

    Measured: 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.

    Measured: 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).

    Measured: 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)

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

  5. Number of Participants With Technical and Procedural Success

    Measured: 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).

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionSep 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
657 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01628159
Sponsor's protocol ID
CL0002-09
Status last verified
Mar 2020
First submitted
19 Jun 2012
Last updated
10 Apr 2020
Data monitoring committee
Yes
Individual data sharing
No: Not at this time.

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

Questions about this trial

What is this clinical trial studying?

A study testing Lutonix Drug Coated Balloon in people with Peripheral Artery Disease, run by C. R. Bard at 64 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Germany, Belgium, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure (time frame: 60 months Post Index Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01628159, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.

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