Avinger has announced that it has successfully completed enrolment in its CONNECT II global clinical trial. A study focused on treatment of peripheral artery disease. CONNECT II is a prospective, multicentre, non-randomised global clinical study that evaluated 100 peripheral artery disease patients with femoropopliteal chronic total occlusion lesions at 15 hospital and clinic sites, including two in the European Union.
As part of the trial, an independent group of physicians are reviewing the angiographic results to determine Ocelot’s safety and efficacy. According to Avinger (manufacturer of this device), it is the first-ever interventional chronic total occlusion (CTO) crossing catheter to use real-time intravascular imaging technology called optical coherence tomography, or OCT. It allows physicians to cross, see and navigate inside totally blocked arteries in the legs of patients suffering from peripheral artery disease.
“We are pleased to reach this significant milestone ahead of schedule and already see promising preliminary data collected,” said John B Simpson, CEO and founder, Avinger. “We appreciate the patient participation and dedicated efforts of our employees, physician investigators and their research staff. Together, we are now one step closer to bringing the Ocelot technology to patients who need it most.”
The company will present CONNECT II aggregate results at the VIVA conference (Las Vegas, USA, 9–12 October 2012), file a 510K with the FDA later this summer, and expects to receive 510K clearance in late 2012. In order to ensure Ocelot is available for use at US CONNECT II sites during the 510K review period, Avinger has also requested FDA approval of an additional 125 patients to be enrolled and treated in a continued access cohort.
“I believe the results from this trial will have a major impact on how physicians treat patients with severe peripheral artery disease. We are pleased that a request for continued access has been submitted. It means the Heart Hospital may be able to continue treating patients with Ocelot in order to quickly improve their mobility and return to a healthier quality of life,” said Matthew Selmon, Heart Hospital Austin, Texas and co-principal investigator for the trial.
“This is the first-ever interventional device that allows us to drill through the totally blocked arteries in the legs while using an integrated camera to see it from the inside,” said Arne Schwindt, St Franziskus Hospital, Muenster, Germany and co-principal investigator in the trial. “This is a major advance for patients suffering from peripheral artery disease, and holds the potential to postpone or entirely avoid surgical bypasses and amputations.”
Ocelot received CE mark in 2011.