levant 2 safety registry

Conditions: Peripheral Artery Disease; Femoropopliteal Artery Occlusion; Femoropopliteal Stenosis

Summary: 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.


Eligibility criteria:
clinical 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; angiographic lesion inclusion criteria: 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.).