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

NCT01628159 | Completed Results DMC

• 1 other identifier: CL0002-09
• Study Type: interventional
• Target: 657
• Locations: 5 countries
• Sites: 64

Brief 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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

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

  60 months Post Index Procedure

Secondary Outcomes (10)

• Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure

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

• Number of Acute Device Success at Time of Index Procedure

  At time of Index Procedure

• 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

  30 days post index procedure

• 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)

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

• Number of Participants With Technical and Procedural Success

  At time of index procedure

Study Arms (1)

Lutonix Drug Coated Balloon

EXPERIMENTAL

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

Lutonix Drug Coated Balloon DEVICE

balloon angioplasty with a drug coated balloon

Also known as: Moxy Drug Coated Balloon

Lutonix Drug Coated Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (64)

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

North County Radiology Medial Group Inc.

Oceanside, California, 92056, United States

Location

St. Joseph's Hospital

Orange, California, 92868, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Washington Cardiology Center

Washington D.C., District of Columbia, 20010, United States

Location

Heart and Vascular Institute

Clearwater, Florida, 33756, United States

Location

Interventional Cardiolgists of Gainesville

Gainesville, Florida, 32605, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Cardiovascular Associates

Elk Grove Village, Illinois, 60007, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Edward Heart / Midwest Research Foundation

Oakbrook Terrace, Illinois, 60181, United States

Location

St. John's Hosptial

Springfield, Illinois, 62710, United States

Location

Allen County Cardiology

Fort Wayne, Indiana, 46802, United States

Location

St. Vincent Heart Center of Indianapolis

Indianapolis, Indiana, 46290, United States

Location

Promise Regional Medical Center

Hutchinson, Kansas, 67502, United States

Location

St. Francis Heart & Vascular Center

Topeka, Kansas, 66606, United States

Location

Massachusetts Genearl Hospital

Boston, Massachusetts, 02114, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

St. John's Hospital

Detroit, Michigan, 48236, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Mercy Hosptial

Coon Rapids, Minnesota, 55433, United States

Location

Forrest General Hospital

Hattiesburg, Mississippi, 39401, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Our Lady of Lourdes Medical Center

Cherry Hill, New Jersey, 08034, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia Universtiy Medical Center

New York, New York, 10032, United States

Location

Wake Heart and Vascular

Raleigh, North Carolina, 27610, United States

Location

Christ Hospital / The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Mid Ohio Cardiology and Vascular Consultants

Columbus, Ohio, 43214, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

Univesrity of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29615, United States

Location

Wellmont Cardiology Services

Kingsport, Tennessee, 37660, United States

Location

East Tennessee Heart Consultants

Knoxville, Tennessee, 37934, United States

Location

Austin Heart P.A.

Austin, Texas, 78705, United States

Location

Medical University of Graz

Graz, A-8036, Austria

Location

Klinikum Klagenfurt

Klagenfurt, Austria

Location

OLV Ziekenhuis

Aalst, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

Flanders Medical Research Program

Dendermonde, Belgium

Location

Hospital Oost-Limburg

Genk, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Herz-Zentrum

Bad Krozingen, Germany

Location

Jewish Hospital

Berlin, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Diakonissenanstalt zu Flensburg

Flensburg, Germany

Location

Hamburg University Cardiovascular Center

Hamburg, Germany

Location

University Clinical Center Heidelberg

Heidelberg, Germany

Location

Herz-Und Gefasszentrum

Immenstadt im Allgäu, Germany

Location

Practice for Interventional Radiology

Kaiserslautern, Germany

Location

Westpfalz Clinic

Kusen, Germany

Location

University Leipzig

Leipzig, Germany

Location

University Magdeburg

Magdeburg, Germany

Location

University of Munich

Munich, Germany

Location

Universtiy Clinic Muenster

Münster, Germany

Location

Ernst von Bergham Clinic

Potstdam, Germany

Location

University of Tübingen

Tübingen, Germany

Location

University Hospital

Bern, Switzerland

Location

Canton Hospital Lucerne

Lucerne, Switzerland

Location

University Hospital, Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31575518 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: BD

anna.lovas@bd.com

763-445-2385

Study Officials

• Kenneth Rosenfield, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Prof. Dierk Scheinert, MD

  University Leipzig

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 26, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 10, 2020
• Results First Posted: April 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (39); DE (15); BE (5); AU (2); CH (3)