Belgian-Italian prospective, single-arm, multicentre study to evaluate the efficacy and safety of BTK treatment with the Luminor 14m paclItaxel coated percutaneous transluminal angiOplaSty balloon catheter of iVascular of 150 subjects with critical limb ischemia .
DESCRIPTION
Device
Luminor 14m
Number of patients
150
Follow up
1-year
Type of lesions
Infrapopliteal lesions in subjects with critical limb ischemia
Patient Characteristics
100% Rutherford 5
71,3% Diabetes
OUTCOMES
Freedom from MALE at 6 months
No embolitsation related to the device detected
Freedom from TLR at 12 months
CONCLUSIONS
BIBLIOS study aims to overcome some of the flaws in BTK trials/treatment
Reintervention rate of only 13.4% at 12 months is superb
MAIN INVESTIGATOR
Dr Koen Deloose
AZ Sint-Blasius Hospital (Dendermonde, BE)
