The BIBLIOS trial has received Ethics Committee (EC) approval, and enrolled its first patient. This announcement comes from Wouter Lansink, who will be treating this first patient at the Vascular Center ZOL Genk in Belgium.
BIBLIOS is a Belgian-Italian prospective, single-arm, multicentre study to evaluate the efficacy and safety of below-the-knee treatment with the Luminor paclitaxel-coated percutaneous transluminal angioplasty balloon catheter (iVascular) with critical limb ischaemia. One hundred and fifty patients will be enrolled from six Italian and Belgian centres.
As stated by Koen Deloose (AZ Sint-Blasius, Dendermonde, Belgium), the trial’s principal investigator, “the benefits of DCBs for critical limb ischaemia are still to be confirmed. Preliminary below-the-knee data with Luminor DCB are promising; therefore, we are looking forward to the results of BIBLIOS, which is set to be representative of real-world population in such [an] indication.”
The primary efficacy endpoint of the BIBLIOS trial is freedom from major adverse limb events at six months. For assessing safety, the primary endpoint of the study is freedom from major adverse limb events or peri-operative death at 30 days.
The secondary endpoints of the BIBLIOS trial include: target vessel functional flow assessment; freedom from clinically driven target lesion revascularisation; amputation free survival; limb salvage; procedural success; wound healing status; and wound healing time, all at six and 12 months.