Cagent Vascular’s Serranator Study Begins

Cagent Vascular Inc., developer of serration technology for vessel dilation in endovascular interventions, has enrolled the first patient in its Serranator vs. Plain Old Balloon Angioplasty (POBA) OCT Study.

This prospective, randomized (two-to-one treatment to control) dual-center study will enroll up to 60 subjects. The trial will use intravascular optical coherence tomography (OCT) imaging to demonstrate the mechanism of action (MOA) of the Serranator and compare the Serration MOA to conventional angioplasty across a wide range of lesion morphologies in below-the-knee arteries.

The study will be taking place at Columbia University Medical Center and Weill Cornell Medicine, led by co-principal investigators Sahil Parikh, M.D., and Brian DeRubertis, M.D. This is believed to be the first study of its kind, a randomized trial utilizing OCT imaging to compare acute outcomes between Serration Angioplasty and POBA. Cardiovascular Research Foundation in New York, N.Y., will serve as the Core Lab for the study.

“Past data has suggested that Serration Angioplasty may provide greater lumen gain versus conventional Plain Balloon Angioplasty, however no study to date has used OCT analysis to definitively show how the Serrations remodel lesions of various morphological characteristics,” Dr. Parikh said. “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.”

Cagent Vascular’s proprietary serration balloon technology is designed to optimize vessel preparation, enhance arterial expansion, and address challenging lesion morphologies in peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI).

The Serranator and Serranator SL-PRO PTA Serration Balloon Catheters are U.S. Food and Drug Administration-cleared balloons using stainless steel micro-serration technology, designed to create linear, interrupted scoring along the endoluminal surface. With 1,000 times more point force compared with POBA, serration occurs during slow-and-low balloon inflation and is designed to aid arterial expansion, effectively achieving luminal gain in all lesion morphologies with minimal recoil. By bringing a differentiated approach to vessel preparation, Cagent Vascular supports physicians in delivering optimal outcomes for patients with PAD and CLTI.

“OCT provides a novel visualization of vascular disease and therapeutic results. With 10x the resolution of IVUS, we believe this study will allow us to understand how Serration Angioplasty and Plain Balloon Angioplasty 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,” Dr. DeRubertis stated.

Cagent Vascular is based in Wayne, Pa.