Biotronik’s Passeo-18 Lux Paclitaxel DCB Evaluated in Head-to-Head BIOPACT Trial

September 23, 2021—Biotronik announced the completion of enrollment of the investigator-initiated BIOPACT randomized controlled trial (RCT). The noninferiority study of the safety and efficacy of paclitaxel drug-coated balloons (DCBs) is comparing Biotronik’s Passeo-18 Lux paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter to the Medtronic In.Pact Admiral paclitaxel-coated PTA balloon catheter.

According to the company, the BIOPACT RCT enrolled 302 patients in Austria, Belgium, France, and Switzerland. The study’s Principal Investigator is Koen Deloose, MD, Head of the Department of Vascular Surgery, AZ Sint Blasius Hospital in Dendermonde, Belgium.

In the study, patients with Rutherford class 2 to 4 disease were randomized 1:1 to either the Passeo-18 Lux DCB or In.Pact Admiral DCB for the treatment of stenotic, nonstented restenotic, or occlusive lesions in the femoropopliteal artery. A noninferiority hypothesis will be tested to compare the clinical performance of Passeo-18 Lux to In.Pact Admiral.

The BIOPACT RCT’s primary efficacy endpoint is freedom from clinically driven target lesion revascularization at 12 months postprocedure. The primary safety endpoint is a composite of freedom from device- and procedure-related death through 30 days postindex procedure as well as freedom from major target limb amputation and clinically driven target vessel revascularization through 12 months postindex procedure. Key secondary endpoints include primary patency, major target limb amputation and all cause of death.

Investigators will collect follow-up data at 1, 6, 12, 24, 36, 48, and 60 months. The primary endpoint is expected to be presented upon completion of 12-month follow-up in late 2022.

“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,” commented Dr. Deloose in the company’s press release. “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.”

In January 2014, Biotronik announced the launch in Europe of the Passeo-18 Lux paclitaxel-releasing PTA balloon catheter. It is not available for sale or use in the United States, advised Biotronik.