Hospital Universitario Getafe
Getafe, Madrid, 28907, Spain
NCT Number: NCT02458911
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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Notify Me18 year and older
All sexes
Observational
Getafe, Madrid, 28907, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Luminor 14 & Luminor 35
Time frame: 1 year
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.
Time frame: 1 year
Freedom of adverse effects (AE). EA are considered in combination: death, amputation and the need for revascularization of the target lesion (safety objective).
iVascular S.L.U.
Industry
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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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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