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

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT01628159

Run by

C. R. Bard

People needed

657

Starts

2012-06-01

Expected to finish

2018-12-01

Last updated by the study team

2020-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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.).

Where it is running

• 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
• Good Samaritan Hospital — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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