Avinger has concluded recruitment of patients in the Scan clinical study, which is comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries.
The Lumivascular technology of Avinger uses OCT to offer real-time vascular imaging to diagnose and treat peripheral artery disease (PAD).
OCT is a light-based and high-definition imaging modality that generates no X-ray radiation, and provides resolution around ten times more than IVUS.
The US Food and Drug Administration (FDA) has approved both diagnostic and therapeutic treatment indications to be used with Avinger’s Pantheris (atherectomy) and Ocelot (CTO-crossing) image-guided catheters.
In June this year, the company has started recruitment of patients in the post-market study at two centers in the US, with an aim of capturing around 115 matched images generated by OCT and IVUS from up to 20 subjects diagnosed with PAD.
According to the company, the trial exceeded the target with greater than 115 OCT and IVUS matched images captured at identical positions within vessel segments from 14 subjects.
The images were submitted to three independent radiologists to assess the matched images and rank them for clarity to identify vessel morphology, abnormal physiology and artifacts.
In addition, vessel measurement will be compared between the two imaging modalities.
Avinger chief medical officer Dr. Jaafer Golzar said: “The SCAN study complements and expands the body of clinical data highlighting the importance of intravascular imaging for the diagnosis and treatment of peripheral arterial disease.
“Drs. Pavillard and Sewall have done a tremendous job enrolling in this important trial. Clinical experience has shown us that OCT is equivalent and in certain situations superior to IVUS for intravascular imaging. Once final results are available from SCAN, we hope to have a robust clinical study supporting this concept.”
Avinger is a commercial-stage medical device firm, which is engaged in the designing and development of an advanced catheter-based system that diagnoses and treats patients with PAD.
The Lumivascular platform is composed of Lightbox imaging console, Ocelot family of chronic total occlusion (CTO) catheters and Pantheris family of atherectomy devices.