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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 through 5 years.

Official Title
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A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Lutonix Drug Coated 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
Intervention Model: Single Group 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>* balloon angioplasty with a drug coated balloon<br>* Other names: Moxy Drug Coated Balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure |  | 60 months Post Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From 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 | Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death. | 1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure | 
| Number of Acute Device Success at Time of Index Procedure | In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint. | At time of Index Procedure | 
| Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR). | 30 days post index procedure | 
| Number of Participants With Freedom From 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 (PPI) |  | 1, 6, 12, 24, 36, 48, and 60 months post index procedure | 
| Number of Participants With Technical and Procedural Success |  | At time of index procedure | 
| Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure | Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS ≥ 2.5) and target lesion revascularization (TLR). | 6, 12, and 24 months post index procedure | 
| Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure | Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The 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. A lower ABI number suggests more Peripheral Arterial Disease. | 6, 12, and 24 months post index procedure | 
| Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure |  | 1, 6, 12, and 24 months post index procedure | 
| Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure | 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 | 
| Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure | Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 and <3.0 Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) <2.5 without prior Clinically Driven TLR) | 6, 12, and 24 months post index procedure |