A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

Study Overview
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Brief Summary
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To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.

Detailed Description
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The study will enroll patients presenting with claudication or ischemic rest pain due to stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful pre-dilatation, subjects determined by the investigator not to require stenting based on defined angiographic criteria will receive the BARD LTX DCB. .

Official Title
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A Prospective, Multicenter, Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries (LEVANT China)

Conditions
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Femoral Artery Stenosis, Femoral Artery Occlusion, Stenosis of Popliteal Arteries, Occlusion of Popliteal Arteries

Intervention / Treatment
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* Device: LTX DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 and < 85 years of age; Documented diagnosis of peripheral arterial disease (PAD) with Rutherford Classification stages 2-4; Patient is willing to provide informed consent and comply with the required - follow up visits, testing schedule and medication regimen; Angiographic Criteria Single lesion or up to two focal lesions (not separated by >3 cm) (total vessel segment length ≤20 cm) in native superficial femoral and/or popliteal arteries; ≥70% diameter 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 ≤7 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 iliac and/or common femoral artery lesions); No vascular interventions, surgical or interventional procedures 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: Breastfeeding or pregnant or planning on becoming pregnant or men intending to father children; Life expectancy of < 2 year; Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; History of stroke within 3 months; History of MI, thrombolysis or angina within 2 weeks of enrollment; Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis); Diagnosed active systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure 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 paclitaxel or paclitaxel related compounds or contrast that cannot be adequately managed with pre- and post-procedure medication; The lesion is a post-DCB restenosis, or within or adjacent to an aneurysm; Ipsilateral retrograde access; There is no normal proximal arterial segment in which duplex flow velocity can be measured; 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 or failed pre-dilatation, defined by a residual stenosis >50% or major flow limiting dissection; Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, embolic protection device, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: LTX DCB<br>Patients treated with Bard Lutonix DCB | Device: LTX DCB<br>* Treatment with a drug-coated balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year | Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio [PSVR] ≥2.5 and/or abnormal waveforms, as determined by an Independent Core Laboratory) and freedom from target lesion revascularization (TLR). | 0-12 months | 
| Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death | Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death | 0-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success |  | 1 month | 
| Technical Success |  | 1 month | 
| Acute Technical Success |  | 1 month | 
| Procedural Success |  | 1 month | 
| Percentage of Subjects with Primary Patency of the Target Lesion |  | 24 months | 
| Target Lesion Revascularization | Proportion of subjects with target lesion revascularization through 24 months | 24 months | 
| Change in Rutherford Classification | Mean change in Rutherford Classification from baseline through 24 months | 24 months | 
| Change in Ankle Brachial Index | Mean change in ankle brachial index from baseline through 24 months | 24 months | 
| Percentage of subjects who died from any cause |  | 24 months | 
| Amputation-free Survival | Percentage of subjects with above-the-ankle amputation-free survival | 24 months | 
| Percentage of subjects with Target Vessel Revascularization |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Superficial Femoral Artery, Proximal Popliteal Artery