iD3 Medical Announces the Start of the BIOPACT-RCT Trial
May 6, 2019—iD3 Medical announced that it has received approval in Belgium to begin the physician-initiated, multicenter, randomized controlled BIOPACT-RCT trial. BIOPACT-RCT will evaluate the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB; Biotronik, Inc.) compared with the In.Pact Admiral DCB (Medtronic) for the treatment of peripheral artery disease (PAD) in the upper leg.
BIOPACT-RCT trial's Principal Investigator is Koen Deloose, MD. The trial's first patient was enrolled by Roel Beelen, MD, at the OLV Hospital in Aalst, Belgium.
According to iD3 Medical, the trial will enroll up to 302 patients. Six Belgian sites have been approved and the company expects approval at four centers in Switzerland with Coprincipal Investigator Christoph Binkert, MD; two centers in Austria with Coprincipal Investigator Marianne Brodmann, MD; and four centers in France with Coprincipal Investigator Yann Gouëffic, MD.
The company advised that the study will enroll patients with Rutherford classification 2 to 4 and a maximum lesion length of 18 cm in the femoropopliteal arteries. Patients will be randomized 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 revascularization at 12 months, defined as any reintervention at the target lesion due to symptoms, a drop of ankle-brachial index (ABI) of > 20%, or a drop of 0.15 compared with the postprocedure ABI.
The primary safety endpoint is a composite of freedom from device- and procedure-related death through 30 days postindex procedure, freedom from major target limb amputation (above the ankle) through 12 months postprocedure, and clinically driven target vessel revascularization through 12 months postindex procedure.
In iD3 Medical’s press release, Dr. Deloose commented, “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 P-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."
The company advised that this is especially related to the ongoing debate on DCB safety concerning a signal of increased long-term mortality with paclitaxel-coated devices based on the publication of Katsanos et al in Journal of the American Heart Association. The FDA and CIRSE statements, as well as additional patient-level data in the long 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 are waiting for approval in other countries.
Dr. Deloose continued: “Also in this BIOPACT-RCT, patient safety is [the] number one priority, and an even closer monitoring of all the enrollments can contribute to the clarification in this critical time for PAD endovascular therapies.”