Deborah Enrolls PAD Patients in CONNECT II Global Clinical Trial
New catheter combined with a camera provides real-time “inside” view of diseased peripheral arteries
Deborah Heart and Lung Center announces its participation in CONNECT II, a global clinical trial conditionally approved by the FDA that gives physicians access to a sophisticated new imaging technology tool to fight Peripheral Arterial Disease (PAD). The technology -- called Ocelot and invented by Avinger -- helps to eliminate the need for bypass surgeries and/or amputations in patients with the disease. Each year, nearly 200,000 amputations occur as a result of PAD.
Jon C. George, M.D., Deborah Attending Cardiac Interventionalist, recently debuted this new imaging technology, making Deborah the first hospital in the Eastern U.S. with access to this technology. As part of CONNECT II, Dr. George’s use of Ocelot helped restore a patient’s blood flow in completely blocked arteries in the patient’s leg through a simple two-millimeter skin incision.
Deborah is one of only 17 sites worldwide, and one of only 14 sites in the United States selected to participate in this clinical trial.
Of key note with Ocelot is its combination of a proprietary peripheral catheter design paired with real-time Optical Coherence Tomography (OCT). This groundbreaking new tool gives physicians a technique to cross segments of the peripheral vascular system that have chronic total occlusions (blockages) using a catheter armed with a camera. Ocelot’s companion Lightbox console displays the OCT image, offering the physician a real-time visualization of the blockages. Prior to the Ocelot trials, physicians had to rely on X-rays to see outside the artery. Now, Ocelot allows them to see inside the artery.
“Ocelot is aptly named for the cat that possesses excellent night vision,” said Dr. George. “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. This is a major advance for patients with PAD, who might be facing losing a limb.” He added: “We are privileged here at Deborah to have access to this wonderful new cutting-edge research technology. By being involved in clinical trials for the next generation of technology, we are assuring Deborah’s patients of the very latest and most-sophisticated PAD care.”
Dr. George, as principal investigator on the CONNECT II trial, has had considerable experience with Ocelot -- along with Richard Kovach, M.D., Deborah’s Chair, Interventional Cardiology -- including evaluating the device in Leipzig, Germany and moderating live case studies in Muenster, Germany as part of the Leipzig Interventional Course.
PAD, affecting between 8 and 12 million adults in the U.S. alone, is caused by a build-up of plaque in the arteries, blocking blood flow to the legs and feet. Because some blockages can become so severe and difficult to penetrate with traditional catheters, patients can undergo invasive bypass surgeries that result in health risks and lengthy, painful recoveries. Patients over 50 often face amputation, the worst-case scenario associated with PAD.
CONNECT II is a prospective, multi-center, non-randomized global clinical study that will evaluate Ocelot on 100 PAD patients with femoropopliteal chronic total occlusion lesions at 14 U.S. sites.
For more information, or to refer a patient for this trial, please contact Linda Dewey, RN, MSN, CCRC, Senior Study Coordinator 609-893-1200 ext. 5023; Fax (Attn: Linda) 609-893-6038 or DeweyL@Deborah.org.