Biotronik’s BIO-OSCAR FIRST Trial Begins Enrollment

December 19, 2024—Biotronik announced the enrollment of the first patients in its BIO-OSCAR FIRST trial, which is designed to confirm the safety and clinical performance of the company’s 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.

According to Biotronik, BIO-OSCAR FIRST is a prospective, multicenter, single-arm observational study involving 16 European sites within CE Mark–accepting territories. The trial aims to enroll 200 patients—100 for ATK lesions and 100 for BTK lesions—in the next 12 months.

BIO-OSCAR FIRST is intended to evaluate Oscar’s performance in a practical clinical setting, noted the company.

The study’s primary endpoint is the procedural success rate with the Oscar device. Procedural success is defined by successful lesion crossing and a residual stenosis of ≤ 30%, without significant Oscar-related procedural complications such as distal embolization, vessel rupture, perforation, or acute occlusion, advised the company.

The first patients were enrolled in the trial by Koen Deloose, MD, and Professor Marianne Brodmann, MD. Dr. Deloose is Head of the Department of Vascular Surgery, AZ Sint Blasius Hospital in Dendermonde, Belgium. Prof. Brodmann is Head of Division of Angiology at the Medical University of Graz in Graz, Austria.

“The Oscar catheter design holds exciting possibilities for peripheral artery disease care, particularly in the more challenging cases,” commented Dr. Deloose in Biotronik’s press release. “This trial will provide key data on how we can better streamline procedures, assess the algorithm of treatment, and reduce the need for reinterventions.”

On December 12, Biotronik announced it had concluded the BIO-OSCAR SOC prospective, multicenter, observational trial, which established the baseline of standard of care that will be used to evaluate the outcomes of the BIO-OSCAR FIRST study. Dr. Deloose presented the BIO-OSCAR SOC findings at the Paris Vascular Insights Course 2024 held December 12-14 in Paris, France.