Cagent Vascular, Inc, the exclusive developer of Serration technology for vessel dilation in endovascular interventions, has announced its 1st patient enrollment of the Serranator vs Plain old balloon angioplasty optical coherence tomography (POBA OCT) study.
The study seeks to confirm benefits of Cagent’s unique Serration balloon angioplasty technology vs. Plain old balloon angioplasty in treating peripheral artery disease in below-the-knee arteries.
This prospective, randomized dual-center study will enroll up to 60 subjects. The study will utilize intravascular optical coherence tomography imaging to demonstrate the mechanism of action of the Serranator and compare the Serration mechanism of action 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, MD, and Brian DeRubertis, MD. This will be the first study of its kind, a randomized trial utilizing optical coherence tomography imaging to compare acute outcomes between Serration angioplasty and Plain old balloon angioplasty.
Cardiovascular Research Foundation in New York 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 optical coherence tomography analysis to definitively show how the Serrations remodel lesions of various morphological characteristics,” said Dr. Parikh. “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.”
“Optical coherence tomography 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,” stated Dr. DeRubertis.
Cagent Vascular remains committed to advancing vascular care by delivering high-quality, clinically effective solutions that improve patient outcomes. The company’s proprietary serration balloon technology is designed to optimize vessel preparation, enhance arterial expansion, and address challenging lesion morphologies in peripheral artery disease and chronic limb-threatening ischemia.
The Serranator and Serranator SL-PRO PTA Serration balloon catheters are US FDA-cleared, novel balloons using stainless steel micro-serration technology, designed to create linear, interrupted scoring along the endoluminal surface. With 1,000x more point force compared with plain-old balloon angioplasty, 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.
