LEVANT 2 Safety Registry

Completed · Not applicable

Conditions studied: Peripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis

In brief

The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.

Key facts

Study ID

NCT01790243

Run by

C. R. Bard

People needed

1189

Starts

2011-07-20

Expected to finish

2018-11-01

Last updated by the study team

2020-06-05

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

• Mission Cardiovascular Research Institute — Fremont, California, United States
• Metro Health Hospital — Wyoming, Michigan, United States
• Jackson Heart Clinic/St. Dominic's Hospital — Jackson, Mississippi, United States
• Mercy Hospital — Springfield, Missouri, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• New York Presbyterian Hospital/Weill Cornell Medical Center — New York, New York, United States
• TriHealth Heart Institute — Cincinnati, Ohio, United States
• Mission Research Institute — New Braunfels, Texas, United States

Full record on ClinicalTrials.gov

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