On 23 February 2012, Avingerannounced the enrolment of the first European patient in the CONNECT II global clinical trial. The first patient was enrolled by Bernhard Reimers at Ospedale di Mirano in Mirano, Italy.
CONNECT II is a multicentre, non-randomised global clinical study designed to evaluate the safety and efficacy of Ocelot, Avinger’s first therapeutic catheter to incorporate optical coherence tomography. Currently CE marked, Ocelot is designed for crossing chronic total occlusions, in the legs while simultaneously using OCT to visualise inside the arteries. Ocelot is the first CTO crossing catheter to incorporate optical coherence tomography.
“This is a major milestone for Avinger and a true testament to the perseverance of all our employees and investors. Many people said we could not do it,” said Avinger’s founder and CEO John B Simpson. “Ocelot and CONNECT II is our first step toward incorporating intravascular imaging into therapeutic catheters. We truly believe this will revolutionise the treatment of vascular disease and amputation prevention.”
In Mirano, Italy, Reimers was also enthusiastic about commencing Avinger’s CONNECT II clinical trial. “With Ocelot’s first-ever advanced imaging technology, physicians treating peripheral arterial disease can see, in real-time, the intricacies of what they are doing inside the blocked arteries of their patients,” he stated after enrolling the first trial patient in Europe. “I am a part of this trial because this new technology provides us a more scientific and controlled way to treat peripheral arterial disease. This disease, if left untreated, often leads to amputation and death, but with Ocelot we believe many of these patients can now be saved.”
More about CONNECT II clinical trial
CONNECT II will evaluate 100 peripheral arterial disease patients with femoropopliteal CTO lesions at 17 sites, including three in the EU, where Ocelot received CE mark in 2011.
The study is designed to evaluate the safety and efficacy of Ocelot, which uses 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.
As part of the trial, an independent group of physicians will review the angiography results to determine crossing efficacy and safety.
Conditional FDA approval to conduct this study was received on 27 January 2012. Co-principal investigators for the trial include Arne Schwindt, St Franziskus Hospital in Muenster, Germany, and Matthew Selmon, Austin Heart Hospital in Austin, USA.