Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.

Study Overview
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Brief Summary
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The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 & luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and restenosis from prior endovascular procedures in this sector.

Official Title
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Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions (Superficial Femoral Artery (SFA), Popliteal Artery (PA) and Tibial Arteries (ATs)) and Restenosis From Prior Endovascular Procedures in This Sector.

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: Paclitaxel-eluting balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes aged at least 18 Primary injuries and restenosis of the infrainguinal sector of AFS, AP and ATs, and intrastent restenosis or post-ATP prior in that sector. Stenosis >50% and occlusions. (image test) Length: 20 to 200 mm Artery diameter: 2-7 mm. Symptomatic patients (grades 2-5 Rutherford-Baker both included; Fontaine II-IV), affected in their quality of life and that accept treatment (moderate / severe claudication patients, critical ischemia without gangrene or injuries severe enough to foresee limb amputation). Exclusion Criteria: Patients with acute or subacute ischemia will be excluded. Existence of flow-limiting lesions in arteries of the in flow or the out flow of the sector or artery under treatment (> 50 % of the arterial diameter). Aneurysmal dilatation in the ipsilateral arterial axis. Intolerance / allergy to heparin, thienopyridine derivatives (clopidogrel , ticlopidine) and aspirin. Hemorrhagic diathesis during the 3 months prior to inclusion. Patients with a life expectancy of less than 12 months. Serious allergy to contrasts or PTX. Inability to cross the lesion with the guide (these cases will be recorded for the analysis as intention to treat). Those participating simultaneously in another clinical trial. Pregnancy or lactation (pregnancy tests on fertiles).

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

| Intervention/Treatment |
| --- |
|Device: Paclitaxel-eluting balloon|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Primary patency (performance target) of the angioplasty (PTA) performed with drug eluting balloons (DEB) in stenotic/occlusive primary lesions, in restenosis of the AFS, AP and ATs, or in stents from previous procedures in these arteries, with follow-up of 12 months. | 1 year | 
| Freedom of adverse events | Freedom of adverse effects (AE). EA are considered in combination: death, amputation and the need for revascularization of the target lesion (safety objective). | 1 year |