WAYNE, PA — Cagent Vascular has announced the enrollment of the first patient in its groundbreaking Serranator vs. POBA OCT Study. This innovative clinical trial aims to evaluate the benefits of the company’s Serration Balloon Angioplasty compared with Plain Old Balloon Angioplasty (POBA) for treating Peripheral Artery Disease (PAD) in below-the-knee arteries.
The dual-center, randomized study will enroll up to 60 subjects across Columbia University Medical Center and Weill Cornell Medicine under the guidance of co-principal investigators Dr. Sahil Parikh and Dr. Brian DeRubertis. Using Optical Coherence Tomography (OCT), a cutting-edge imaging technology offering 10 times the resolution of intravascular ultrasound, the study will visually and quantitatively assess the mechanism of action (MOA) of Serration Angioplasty.
“Past data has suggested that Serration Angioplasty may provide greater lumen gain versus conventional Plain Balloon Angioplasty,” stated Dr. Parikh. “However, no study to date has definitively shown how the Serrations remodel lesions of various morphologies using OCT analysis. This research will provide valuable insights for optimizing clinical outcomes.”
Dr. DeRubertis added, “OCT allows for unparalleled visualization of vascular disease and treatment results. This trial represents an important step in understanding how Serration Angioplasty interacts with arterial structures.”
The Cardiovascular Research Foundation in New York will serve as the Core Lab for the study, which is the first randomized trial to deploy OCT imaging for comparing the two angioplasty methods.
By leveraging advanced imaging and a rigorous methodology, Cagent Vascular aims to generate data that will guide clinicians in identifying the ideal cases for its technology. The outcomes of this study could potentially set new benchmarks in PAD treatment and pave the way for wider adoption of Serration Angioplasty.
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