LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

Study Overview
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Brief Summary
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LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon

Detailed Description
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LEGDEB2 is a Global Registry aimed to prospectively collect and assess global safety and efficacy data on the Legflow Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal and/or below-the-knee and/or iliac arteries in real world patient population.

Official Title
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The LegDeb2 Global Registry for the Treatment of Superficial Femoral, Popliteal or Below-The-Knee Artery Lesions Using the Legflow DrugEluting Balloon

Conditions
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Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases, Popliteal Artery Stenosis, Critical Limb Ischemia

Intervention / Treatment
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* Device: Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years or minimum age as required by local regulations. Subject with documented diagnosis of lower extremities arterial disease (LEAD). Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days. Positive diagnostic indication for PTA with a DEB in accordance with the Instructions For Use (IFU) of the Legflow DEB. Adequate distal run-off to the ankle (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment. Adequate inflow (≤ 50% diameter stenosis) either pre-existing or successfully re-established prior to target lesion treatment. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before enrollment. Signed and dated Patient Informed Consent (PIC) form. Ability and willingness to comply with the clinical investigation plan (CIP). Life expectancy, in the Investigator's opinion, of at least 12 months Exclusion Criteria: High probability of non-adherence to CIP follow-up requirements. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm. Acute or sub-acute thrombus in the target vessel. Target lesion also requires treatment with alternative drug eluting technology-based therapy or other antiproliferative therapy (cryoplasty, brachytherapy). Plan for surgical or interventional procedure within 30 days after the study procedure (except for bilateral target limb treatment). Known allergies or sensitivities to heparin, aspirin, other anti- coagulant/anti-platelet therapies, and/or paclitaxel.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Cohort<br>Subjects with symptoms of intermittent claudication and/or critical limb ischemia (Rutherford Class 2-3-4-5-6) with angiographic evidence of femoropopliteal-below-the-knee arterial occlusion or stenosis | Device: Drug Coated Balloon<br>* Legflow Drug Coated Balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Freedom from Clinically driven TLR | Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: Any re-intervention within the target lesion(s) due to symptoms | 12 Months | 
| Safety: Freedom from MAE | A composite of freedom from device- and procedure-related mortality through 30 days, freedom from device or procedure related mortality, freedom from any cardiac or cardiovascular death, freedom from major target limb amputation | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from MALE and MACCE | MALE is defined as acute limb ischemia, urgent revascularization or mayor amputation of the treated limb MACCE is defined as Death, Acute myocardial infarction or stroke | 30 days, 6 Months, 12 Months, 24 Months, 36 Months | 
| Freedom from all cause mortality | all cause mortaliy | 30 days, 6 Months, 12 Months, 24 Months, 36 Months | 
| Freedom from CD-TLR | Clinically driven Target Lesion Revascularization | 24 Months, 36 Months | 
| Freedom from CD-TVR | Clinically driven Target Vessel Revascularization Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms | 6 Months, 12 Months, 24 Months, 36 Months | 
| Freedom from Major target limb amputation | Major target limb amputation | 30 days, 6 Months, 12 Months, 24 Months, 36 Months | 
| Primary sustained clinical improvement | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects | 6 Months, 12 Months, 24 Months, 36 Months | 
| Device Success | Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP). | Day 1 | 
| Procedural Success | Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate | Day 1 | 
| Clinical Success | Clinical success is defined as procedural success without in hospital MALE and/or MACCE | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenosis, Drug Coated Balloon, Paclitaxel, Artery Disease