LEVANT 2 Safety Registry

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)

Conditions
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Peripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis

Intervention / Treatment
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* Device: Lutonix Drug Coated Balloon
* Device: Standard PTA Balloon


Participation Criteria
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Eligibility Criteria
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Clinical 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; Angiographic Lesion Inclusion Criteria: 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; Lesion is located at least 3 cm from any stent, if target vessel was previously stented; Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix; Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion; 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. 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); 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; 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: 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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lutonix Drug Coated Balloon<br>Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter | Device: Lutonix Drug Coated Balloon<br>* Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.<br>|
| Active Comparator: Standard Uncoated Angioplasty Balloon<br>PTA Catheter | Device: Standard PTA Balloon<br>* Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. |  | From index procedure to 60 months Post Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | Number of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint) | 30 days post index procedure | 
| Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure |  | 1, 6, 12, 24, 36, 48, and 60 months post index procedure (PPI) | 
| Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure | Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR). | 6, 12, and 24 months post index procedure | 
| Number of Acute Device Success at Time of Index Procedure | Device Success was defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system. | At time of index procedure | 
| Number of Participants With Technical and Procedural Success | Technical Success is defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent. Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure. | At time of index procedure | 
| Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure |  | 6, 12, and 24 months post index procedure | 
| Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure | Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 and <3.0 at 6, 12, and 24 months post index procedure. DUS PSVR was calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase. | 6, 12, and 24 months post index procedure | 
| Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline | The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened. | 6, 12, and 24 months post index procedure | 
| Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline | Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. | 6, 12, and 24 months from baseline |