iD3 Medical has announced that it has received approval in Belgium to initiate a randomised controlled trial, BIOPACT-RCT: a physician-initiated multicentre trial evaluating the safety and efficacy of Biotronik’s Passeo-18 Lux drug-coated balloon (DCB) for the treatment of peripheral arterial disease (PAD) in the upper leg compared to the IN.PACT Admiral DCB (Medtronic). The first patient was enrolled by Roel Beelen in the OLV-hospital (Aalst, Belgium).
BIOPACT-RCT will be led by Koen Deloose (AZ Sint-Blasius Hospital, Dendermonde, Belgium) as principle investigator. The trial will enrol up to 302 patients. Six Belgian sites already have their approval. iD3 Medical also expects approval in Switzerland (four centres, co-principal investigator Christoph Binkert), Austria (two centres, co-principal investigator Marianne Brodmann) and France (four centres, co-principal investigator Yann Gouëffic). Included patients, Rutherford classification 2 to 4 with a max study lesion length of 18cm in the femoropopliteal arteries, will be randomised 1:1 to undergo treatment with either the Passeo-18 Lux or the IN.PACT Admiral DCB. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularisation at 12 months, defined as any reintervention at the target lesion due to symptoms, drop of ankle-brachial-index (ABI) of more than 20% or a drop of 0.15 compared to the post-procedure ABI. The primary safety endpoint is a composite of freedom from device- and procedure-related death through 30 days post-index procedure, freedom from major target limb amputation (above-the-ankle) through 12 months post-procedure and clinically-driven target vessel revascularisation through 12 months post-index procedure.
In iD3 Medical’s press release, Deloose comments: “Although we have already a lot of safety and efficacy data available on the Passeo-18 Lux through the BIOLUX P-I, P-II and the ongoing BIOLUXP-III trial, a more in depth, head-to-head comparison with today’s market leading DCB will offer more answers about the relative performance of DCBs and potential class effects. Especially related to the ongoing debate on DCBs safety concerning a signal of increased long-term mortality with paclitaxel-coated devices, based on the publication of Katsanos et al in the Journal of the American Heart Association, and the FDA- and CIRSE-statements here about additional patient level data, also in the longer run, are essential. Adapted patient informed consents, data safety monitoring board and clinical event committee instructions, and prolonged patient follow up procedures for the BIOPACT-RCT are already implemented in the Belgian approval and waiting for approval in the other countries.”
Deloose continued: “Also in this BIOPACT-RCT, patient safety is number one priority and an even closer monitoring of all the enrolments, can contribute to the clarification in this critical time for peripheral arterial disease endovascular therapies.”