Avinger Begins Study on OCT, IVUS for Treating PAD

Medical device developer Avinger Inc. has begun a study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as imaging tools for diagnosing and treating peripheral artery disease (PAD). Avinger designs and develops image-guided, catheter-based systems that use OCT.

“OCT and IVUS have been well-accepted imaging modalities for the diagnosis and treatment of atherosclerotic disease,” said Dr. Luke Sewall, an interventional radiologist and president of Vascular and Interventional Professionals, who will serve as a physician investigator in the study.“Published data have shown that intravascular imaging may allow a clinician to more accurately assess vessel size, plaque characteristics, anatomical features, and the adequacy of interventional results. OCT and IVUS imaging also have the potential to limit the amount of radiation to which physicians and catheterization lab staff are exposed, and also reduce the volume of contrast agent used in the intervention, which can be particularly important in successfully treating patients suffering from impaired kidney function.”

The study will enroll up to 20 subjects diagnosed with peripheral artery disease at two centers in the U.S., with the goal of acquiring at least 115 matched images generated by OCT and IVUS imaging for analysis. The OCT and IVUS images will be captured at identical positions within vessel segments so that a comparison can be made between the two imaging modalities.

“As a regular user of diagnostic IVUS to plan treatment and assess results after the delivery of therapy, I have found that having an intravascular view of arterial structures and disease distribution leads to better results for my patients [than] if I relied solely on fluoroscopy,” said Dr. Edward Pavillard, a vascular surgeon at PA Vascular Institute and another physician investigator in the study. “Given the correlation between the use of intravascular imaging and clinical outcomes, I am excited to participate in a study that will help expand the incorporation of OCT into the treatment paradigm for peripheral interventions.”

The results of the study are intended to support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries similar to the reimbursement currently provided for the use of IVUS in this setting.