Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment

Study Overview
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Brief Summary
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The aim of this observational study is to evaluate the outcomes and safety of the Paclitaxel-eluted balloon catheter ELUTAX SV for treatment of peripheral arterial disease (PAD) in below-the-knee vessels

Detailed Description
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The management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. This study will record the use of ELUTAX SV-DEB under real life conditions in a representative sample.The investigators will generate new data in observing the outcome and the safety of the Elutax SV drug-eluting balloons for change in Rutherford clinical category from baseline to 6 and 12 month follow-up visits.

Official Title
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A Prospective Observational Study Using Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment

Conditions
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Critical Limb Ischemia, Peripheral Artery Disease

Intervention / Treatment
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* Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paclitaxel-eluting balloon angioplasty in below-the-knee lesions with ELUTAX SV-DEB Age ≥ 18 years Signed informed consent documented Critical Limb Ischemia (CLI) in the target limb prior to the study Rutherford Category 4, 5 or 6 ≥70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stent restenosis/occlusion of target lesion Patent inflow artery Target vessel(s) diameter between 2 and 4 mm Target vessel(s) reconstitute(s) at or above the ankle Exclusion Criteria: Life expectancy below 50% within the next 12 months (as judged by the investigator) Planned major index limb amputation Acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis) Application of DEB-eluting balloons except from ELUTAX SV in the same target limb (POBA is allowed) Patient unwilling or unlikely to comply with follow-up schedule

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 |
| --- | --- |
| Patients with critical limb ischemia<br>Patients undergoing endovascular intervention of below-the-knee arteries with ELUTAX SV DEB (drug-eluting balloon). | Device: Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV<br>* Angioplasty for revascularization in below-the-knee arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Rutherford Classification | Change of Rutherford stage to baseline at Follow-up visits | after 6 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Below-the-knee