Avinger has announced the enrolment of the first US patient in the multicentre, non-randomised CONNECT II global clinical trial designed to evaluate the safety and efficacy of the company’s Ocelot, the first-ever chronic total occlusion crossing catheter to use real-time intravascular optical coherence tomography (OCT) imaging technology.
Ian Cawich, Arkansas Heart Hospital, USA, enrolled the first US patient on 6 March. The first patient in Europe was enrolled in February by Bernhard Reimers at Ospedale di Mirano in Mirano, Italy.
CONNECT II will evaluate 100 peripheral artery disease patients with femoropopliteal chronic total occlusion lesions at 17 sites, including three in the European Union, where Ocelot received CE mark in 2011.
“We are participating in CONNECT II because our patient, if treated with other current options on the medical market, could face amputation and death,” said 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 miracle to our patient.”
The Ocelot catheter uses OCT technology as a navigation tool with the goal of traversing chronic total occlusions more safely and effectively as part of a procedure to restore blood flow back to normal in the legs. It allows physicians, in real time, to see what is happening inside the arteries during the actual intervention, giving patients a better chance to receive the best treatment possible during a single hospital visit.
“We hope that physicians using Ocelot can now help prevent even more leg amputations in people suffering from peripheral artery disease,” said John B Simpson, founder and CEO, Avinger.
Conditional FDA approval to conduct this study was received on 27 January 2012. Co-principal investigators for the trial are Arne Schwindt, St. Franziskus Hospital, Muenster, Germany, and Matthew Selmon, Austin Heart Hospital, Austin, Texas, USA.