REFLOW Study, Investigating the Efficacy of the LEGFLOW DCB in TASC C&D Fempop Lesions

Study Overview
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Brief Summary
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A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm. Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the treatment of long femoropopliteal lesions (TASC C&D).

Official Title
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ReFlow Study, a Physician-initiated Trial Investigating the Efficacy of the LegFlow Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter for the Treatment of Femoropopliteal Lesions Longer Than 15cm (TASC C&D Lesions).

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: LEGFLOW DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presenting a score from 2 to 5 following Rutherford classification Patient is willing to comply with specified follow-up evaluations at the specified times Patient is >18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient has a projected life expectancy of at least 12 months Prior to enrolment, the guidewire has crossed target lesion Patient is eligible for treatment with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter Male, infertile female or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure De novo lesion located in the femoropopliteal arteries suitable for endovascular therapy The target lesion is located within the native femoropopliteal artery The length of the target lesion is > 150mm and considered as TASC C or D lesion according to the TASC II classification. The target lesion has angiographic evidence of stenosis > 50% or occlusion which can be passed with standard guidewire manipulation Target vessel diameter visually estimated is >4mm and <6.5 mm There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention Exclusion Criteria: Patient refusing treatment Presence of a stent in the target lesion that was placed during a previous procedure Untreated flow-limiting inflow lesions Any previous surgery in the target vessel (including prior ipsilateral crural bypass) Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis Previous bypass surgery in the same limb Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site Perforation at the angioplasty site evidenced by extravasation of contrast medium Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II Patients with uncorrected bleeding disorders Aneurysm located at the level of the SFA Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis) Severe medical comorbidities (untreated CAD/CHF, sever COPD, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy Major distal amputation (above the transmetatarsal) in the study limb or non-study limb Septicemia or bacteremia Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis >30% or ipsilateral iliac treatment conducted after the target lesion procedure Use of thrombectomy, atherectomy or laser devices during procedure Any patient considered to be hemodynamically unstable at onset of procedure Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period

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: LEGFLOW DCB<br>patients treated with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter | Device: LEGFLOW DCB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency rate at 1 & 6 month follow-up |  | 1 month, 6 months | 
| Technical success |  | during procedure, at baseline | 
| Freedom from TLR at 1,6 and 12-month follow-up |  | 1 month, 6 months, 12 months | 
| Clinical success at follow-up, defined as an improvement of Rutherford classification at all follow-up time points |  | 12 months | 
| Serious adverse events |  | 12 months |