Cagent Vascular has announced its first patient enrolment in the Serranator versus plain balloon angioplasty optical coherence tomography (OCT) study.
This prospective, randomised (2:1 treatment to control) dual-centre study will enrol up to 60 patients. The study will utilise intravascular 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 and Brian DeRubertis. A press release reports that this will be the first study of its kind, a randomised trial utilising OCT imaging to compare acute outcomes between serration angioplasty and plain balloon angioplasty. Cardiovascular Research Foundation in New York, USA 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,” said Parikh. “The information we gather in this study will be valuable in emphasising guidance on what clinical presentations may be most appropriate for intervention with serration technology.”
“OCT provides a novel visualisation of vascular disease and therapeutic results. With 10x the resolution of IVUS [intravascular ultrasound], 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 DeRubertis.
