Cagent Begins Serranator OCT Study of Serration Angioplasty Versus POBA in BTK Arteries

April 10, 2025—Cagent Vascular, Inc. announced that the first patient was enrolled in the Serranator OCT study. The study will use intravascular optical coherence tomography (OCT) imaging to demonstrate the mechanism of action (MOA) of the company’s Serranator percutaneous transluminal angioplasty (PTA) serration balloon technology and compare it to plain old balloon angioplasty (POBA) across a range of lesion morphologies in below-the-knee arteries.

According to the company, the prospective, randomized (2:1 treatment to control), dual-center study will enroll up to 60 patients at Columbia University Medical Center and Weill Cornell Medicine in New York, New York. Coprincipal Investigators Sahil Parikh, MD, and Brian DeRubertis, MD, will lead the study. The Cardiovascular Research Foundation in New York will serve as the core lab for the study.

“Past data [have] suggested that serration angioplasty may provide greater lumen gain versus conventional POBA; however, no study to date has used OCT analysis to definitively show how the serrations remodel lesions of various morphological characteristics,” commented Dr. Parikh in Cagent Vascular’s press release. “The information we gather in this study will be valuable in emphasizing guidance on what clinical presentations may be most appropriate for intervention with serration technology.”

Dr. DeRubertis added, “OCT provides a novel visualization of vascular disease and therapeutic results. With 10 times the resolution of intravascular ultrasound, we believe this study will allow us to understand how serration angioplasty and POBA interact with the intima, internal elastic lamina, and media. We’re eager to assess this visually and quantitatively in this first-of-its-kind study.”

Cagent Vascular’s FDA-cleared Serranator and Serranator SL-Pro PTA catheters are designed to create linear, interrupted scoring along the endoluminal surface in the treatment of patients with peripheral artery disease or chronic limb-threatening ischemia, stated the company.