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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-eluting balloon | Device |
|
| 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 |
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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.
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:
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Patients with peripheral artery disease due to occlusive lesions, stenosis of ingraguinal arteries and restenosis after previous angioplasty with/without stent in that sector
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Getafe | Getafe | Madrid | 28907 | Spain |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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