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

NCT ID: NCT01628159

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 657 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lutonix Drug Coated Balloon

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

Group Type: EXPERIMENTAL

Lutonix Drug Coated Balloon

Intervention Type: DEVICE

balloon angioplasty with a drug coated balloon

Interventions

Lutonix Drug Coated Balloon

balloon angioplasty with a drug coated balloon

Intervention Type: DEVICE

Other Intervention Names

Moxy Drug Coated Balloon

Eligibility Criteria

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;

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Rosenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Prof. Dierk Scheinert, MD

Role: PRINCIPAL_INVESTIGATOR

University Leipzig

Locations

Good Samaritan Hospital

Los Angeles, California, United States

North County Radiology Medial Group Inc.

Oceanside, California, United States

St. Joseph's Hospital

Orange, California, United States

University of California Davis

Sacramento, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington Cardiology Center

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

Heart and Vascular Institute

Clearwater, Florida, United States

Interventional Cardiolgists of Gainesville

Gainesville, Florida, United States

Munroe Regional Medical Center

Ocala, Florida, United States

Cardiovascular Associates

Elk Grove Village, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Edward Heart / Midwest Research Foundation

Oakbrook Terrace, Illinois, United States

St. John's Hosptial

Springfield, Illinois, United States

Allen County Cardiology

Fort Wayne, Indiana, United States

St. Vincent Heart Center of Indianapolis

Indianapolis, Indiana, United States

Promise Regional Medical Center

Hutchinson, Kansas, United States

St. Francis Heart & Vascular Center

Topeka, Kansas, United States

Massachusetts Genearl Hospital

Boston, Massachusetts, United States

Detroit Medical Center

Detroit, Michigan, United States

St. John's Hospital

Detroit, Michigan, United States

Michigan Heart

Ypsilanti, Michigan, United States

Mercy Hosptial

Coon Rapids, Minnesota, United States

Forrest General Hospital

Hattiesburg, Mississippi, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Our Lady of Lourdes Medical Center

Cherry Hill, New Jersey, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia Universtiy Medical Center

New York, New York, United States

Wake Heart and Vascular

Raleigh, North Carolina, United States

Christ Hospital / The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Mid Ohio Cardiology and Vascular Consultants

Columbus, Ohio, United States

Jobst Vascular Institute

Toledo, Ohio, United States

Univesrity of Toledo Medical Center

Toledo, Ohio, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

Wellmont Cardiology Services

Kingsport, Tennessee, United States

East Tennessee Heart Consultants

Knoxville, Tennessee, United States

Austin Heart P.A.

Austin, Texas, United States

Medical University of Graz

Graz, , 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 im Allgäu, , Germany

Practice for Interventional Radiology

Kaiserslautern, , Germany

Westpfalz Clinic

Kusen, , Germany

University Leipzig

Leipzig, , Germany

University Magdeburg

Magdeburg, , Germany

University of Munich

Munich, , Germany

Universtiy Clinic Muenster

Münster, , 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

Countries

United States; Austria; Belgium; Germany; Switzerland

References

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.

Reference Type: DERIVED

PMID: 31575518 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CL0002-09

Identifier Type: -

Identifier Source: org_study_id