March 14, 2012—Avinger, Inc. (Redwood City, CA) announced commencement of the CONNECT II global clinical trial of the company’s Ocelot catheter, which uses optical coherence tomography (OCT) for crossing chronic total occlusions (CTO) in patients with peripheral arterial disease.
The first patient in the United States was enrolled on March 6 by Ian Cawich, MD, at the Arkansas Heart Hospital in Little Rock. Bernhard Reimers, MD, enrolled the trial’s first European patient in February at Ospedale di Mirano in Mirano, Italy.
According to Avinger, CONNECT II will evaluate the safety and efficacy of Ocelot, which is designed for crossing CTOs in the legs while simultaneously using OCT to navigate inside the arteries. The device allows physicians to see what is happening inside the arteries during the actual intervention in real time.
CONNECT II is a prospective, multicenter, nonrandomized global clinical study. The trial will evaluate 100 peripheral arterial disease patients with femoropopliteal CTO lesions at 17 sites, including three in the European Union, where Ocelot received CE Mark approval in 2011. 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 received conditional approval to conduct the study from the US Food and Drug Administration on January 27, 2012. Co-Principal Investigators for the trial include Arne Schwindt, MD, in Muenster, Germany, and Matthew Selmon, MD, in Austin, Texas.
"We are participating in CONNECT II because our patient, if treated with other current options on the medical market, could face amputation and death," commented Dr. Cawich. "With Avinger's Ocelot, we believe this patient can be saved right now from both. The timing of this trial feels like a bit of a miracle to our patient."
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