Biotronik is proud to announce the completion of enrolment of the investigator-initiated BIOPACT randomised controlled trial (RCT). This non-inferiority study evaluates the safety and efficacy of paclitaxel drug-coated balloons (DCBs), comparing the Biotronik Passeo-18 Lux paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter to the IN.PACT Admiral paclitaxel-coated PTA balloon catheter (Medtronic).
The study enrolled 302 patients in Austria, Belgium, France and Switzerland and will collect follow-up at one, six, 12, 24, 36, 48 and 60 months. Patients with Rutherford class 2–4 disease were randomized 1:1 to either the Passeo-18 Lux DCB or IN.PACT Admiral DCB for the treatment of stenotic, non-stented restenotic or occlusive lesions in the femoropopliteal artery. A non-inferiority hypothesis will be tested to compare the clinical performance of Passeo-18 Lux to IN.PACT Admiral.
The primary efficacy endpoint is freedom from clinically-driven target lesion revascularisation at 12 months post-procedure. 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 and clinically-driven target vessel revascularisation through 12 months post-index procedure. Key secondary endpoints include primary patency, major target limb amputation and all cause of death.
“I am thrilled about this milestone for the BIOPACT RCT and thank all of our investigators for their participation and contribution to the fast enrolment despite the pandemic-induced challenges in patient care over the last year and a half,” said principal investigator Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium). “Having more head-to-head data is critical to better understand differences in device design and drug dosage and the more data we can add to the safety debate of paclitaxel-coated balloons, the better. We eagerly await the follow-up results of this trial.”
“This head-to-head clinical trial will add to the already extensive evidence supporting our Passeo-18 Lux DCB,” said Alexander Uhl, president Vascular Intervention at Biotronik. “We look forward to these data confirming Passeo-18 Lux’s position amongst the leading DCBs.”
The primary endpoint is intended to be presented upon completion of 12-month follow-up in late 2022.