Cagent Vascular has announced its first patient enrolment in the Serranator versus plain balloon angioplasty optical coherence tomography (OCT) study.
This prospective, randomized (2:1 treatment to control) dual-center study will enroll up to 60 patients. The study will utilize 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, MD, an interventional cardiologist, and vascular surgeon Brian DeRubertis, MD. A company press release reports that this will be the first study of its kind, a randomized trial utilizing OCT imaging to compare acute outcomes between serration angioplasty and plain balloon angioplasty.
“OCT provides a novel visualization 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.
