Biotronik announced this week that it has enrolled the first patients in its BIO-OSCAR FIRST trial, a study designed to confirm the safety and clinical performance of the Oscar peripheral multifunctional catheter for dilation of lesions in the femoral, popliteal and infrapopliteal arteries, including both above-the-knee (ATK) and below-the-knee (BTK) lesions.
The BIO-OSCAR FIRST trial is a prospective, multicentre, single-arm observational study involving 16 European sites within CE mark-accepting territories. Over the next 12 months, the trial aims to enrol 200 patients—100 for ATK and 100 for BTK lesions. This study is designed to evaluate Oscar’s performance in a practical clinical setting.
“The Oscar catheter design holds exciting possibilities for peripheral arterial disease (PAD) care, particularly in the more challenging cases,” says Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium). “This trial will provide key data on how we can better streamline procedures, assess the algorithm of treatment and reduce the need for reinterventions.”
The first patients were included in the trial by Deloose and Marianne Brodmann (Medical University of Graz, Graz, Austria).
The primary endpoint of the study is the Oscar device procedural success rate, which is defined by successful lesion crossing and a residual stenosis of ≤30%, without significant Oscar-related procedural complications such as distal embolisation, vessel rupture, perforation, or acute occlusion.
“With the BIO-OSCAR FIRST study, we’re looking to validate Oscar’s potential to simplify complex interventions while confirming safety and efficacy,” says Stuart Perks, Vice President at Biotronik Vascular Intervention. “Many physicians have reported excellent procedural outcomes with Oscar. Our focus now is to generate the hard clinical evidence to support clinicians’ decision-making and the care they deliver to their patients.”
A company press release details that the Oscar device is an all-in-one solution indicated for femoral, popliteal and infrainguinal lesions. The Oscar support catheter and dilator are used in tandem to enable lesion access and crossing with a compatible guidewire, offering a range of support strength dependent on the extension of the dilator.
