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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
Timeframe: From index procedure to 60 months Post Index Procedure
✕. 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);