Avinger, a medical device manufacturer of multifunctional catheters, has enrolled the first US patient with peripheral artery disease (PAD) for the CONNECT II global clinical trial conducted at the Arkansas Heart Hospital, US.
Connect II is a multicentre non-randomised global clinical study that will evaluate 100 PAD patients with femoropopliteal chronic total occlusion (CTO) lesions for the safety and efficacy of Ocelot, a CTO crossing catheter.
CE marked, Ocelot is designed for crossing completely blocked arteries in the legs while simultaneously using optical coherence tomography (OCT) to visualise inside the arteries.
The Ocelot employs real-time OCT imaging as a navigation tool to traverse completely blocked arteries precisely where needed, in order to restore blood flow back to normal in the legs. As part of the trial, an independent group of physicians will review the angiography results to determine Ocelot's crossing efficacy and safety, the company said. Ocelot allows physicians to observe what's happening inside the arteries during the actual intervention, providing patients with a chance to receive the best treatment possible during a single hospital visit.
Avinger founder and CEO John Simpson said they believe physicians using Ocelot can now help prevent leg amputations in people suffering from PAD. In January 2012, the company received conditional US Food and Drug Administration (FDA) approval to conduct the study.
Co-principal investigators for the trial include Arne Schwindt of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon of the Austin Heart Hospital in Austin, Texas, US.
Avinger develops next-generation catheter-based technologies for the treatment of PAD.