Avinger, a developer of next-generation catheter-based technologies, has enrolled first US patient for the Connect II global clinical trial.
The multi-center, non-randomized study, which will enroll 100 peripheral artery disease (PAD) patients with femoropopliteal chronic total occlusions (CTO) lesions, is designed to assess the safety and efficacy of Ocelot, a CTO crossing catheter which uses real-time intravascular imaging technology called optical coherence tomography (OCT).
The Ocelot catheter utilizes OCT technology as a navigation tool with the goal of traversing CTOs more safely and effectively as part of a procedure to restore blood flow back to normal in the legs.
The catheter also facilitates physicians, in real time, to see what’s happening inside the arteries during the actual intervention, giving patients a better chance to receive the best treatment possible during a single hospital visit.
Avinger founder and CEO John Simpson said the company hope that physicians using Ocelot can now help prevent even more leg amputations in people suffering from PAD.