BIBLIOS Trial

Belgian-Italian prospective, single-arm, multicentre study to evaluate the efficacy and safety of BTK treatment with the Luminor-14 paclItaxel coated percutaneous transluminal angiOplaSty balloon catheter of iVascular of 150 subjects with critical limb ischemia .

Device: luminor 14m

Number of patients: 150

Type of lesion: Infrapopliteal lesions in subjects with critical limb ischemia

Efficacy endpoint

  • Freedom from major adverse events (MALE) at 6 months

 

Safety endpoint

  • Freedom from MALE or Peri-operative death (POD) at 30 days

Secondary endpoints

  • Target Vessel Functional Flow Assessment at 6 and 12 months
  • Freedom from clinical driven target lesion revascularization (CD-TLR) at 6 and 12 months
  • Amputation free survival at 6 and 12 months
  • Limb salvage at 6 and 12 months
  • Procedural success
  • Wound healing status
  • Wound healing time

Dr Koen Deloose – AZ Sint-Blasius Hospital (Dendermonde, BE)

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