BIOPACT Head-to-Head Non-Inferiority Randomized Controlled Trial Completes Enrollment

BIOTRONIK is proud to announce the completion of enrollment of the investigator-initiated BIOPACT randomized 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 PTA balloon catheter to the Medtronic IN.PACT Admiral Paclitaxel-coated PTA balloon catheter.

The study enrolled 302 patients in Austria, Belgium, France and Switzerland and will collect follow-up at 1, 6, 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 revascularization 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 revascularization 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 enrollment despite the pandemic-induced challenges in patient care over the last year and a half,” said Principal Investigator Dr. Koen Deloose, Head of the Department of Vascular Surgery, AZ Sint Blasius Hospital in 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 Dr. 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.

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Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter is not available for sale or use in the United States.

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