The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.
Study Type
OBSERVATIONAL
Enrollment
132
POBA
DCB
LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
Graz, Austria
Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
Vienna, Austria
Vascular Research Center Bornheiden, Imelda Hospital
Bonheiden, Belgium
Overall survival
Overall survival at five years after index procedure, defined as death from any cause
Time frame: 60 months
Overall survival, defined as the time in days after index procedure to date of death from any cause.
Time frame: 60 months
Major amputations of target extremities
Time frame: 60 months
Clinically-driven target lesion revascularization
Time frame: 60 months
Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.
Time frame: 60 months
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A.Z. Sint-Blasius
Dendermonde, Belgium
Clinic of Cardiology and Angiology II Bad Krozingen
Bad Krozingen, Germany
Gefäßzentrum am KEH
Berlin, Germany
University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie)
Leipzig, Germany
Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum
Rosenheim, Germany