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.
This trial is active, not recruiting.
|Condition||peripheral vascular disease|
|Start date||May 2014|
|End date||May 2017|
|Trial size||215 participants|
|Trial identifier||NCT02458911, Luminor|
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.
time frame: 1 year
Freedom of adverse events
time frame: 1 year
Male or female participants at least 18 years old.
- 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).
- 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).
|Official title||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.|
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