DETROIT — The DMC Cardiovascular Institute announced Wednesday that it will participate in Connect II, a global clinical trial conditionally approved by the FDA that gives physicians access to Ocelot, a new imaging technology tool to fight Peripheral Arterial Disease.
The new technology helps to eliminate the need for bypass surgeries and/or amputations in patients with the disease. With only 14 hospitals across the United States participating, currently DMC CVI is one of two Michigan hospitals participating.
Each year, nearly 200,000 amputations occur as a result of PAD. As part of the clinical trial, co-investigator, Mahir Elder, M.D., Medical Director of both the Cardiac Care Unit and Endovascular Medicine, will use Ocelot on enrolled patients to help restore blood flow in completely blocked arteries in patients’ legs through a simple two-millimeter skin incision, helping to avoid amputation.
Elder trains doctors from across the country in advanced, complex procedures.
“Research is a vital part of practicing medicine, so to be involved in a clinical trial is an opportunity to help clear the pathway for new solutions that help the clinician help the patient,” Elder said. “We’ve been trying to find better ways to dislodge severe, almost impenetrable blockages that occur in our most serious PAD cases. I intend to apply my skills and expertise to this clinical trial to help determine whether the Ocelot technology could be our new tool. I have patients right now, today, who could benefit.”
“Our goal is always to restore and preserve health. But for some patients, even our most advanced treatments have not been enough to prevent amputation, a result that is devastating and challenging for patients and their families,” said Theodore Schreiber, M.D., president of the DMC Cardiovascular Institute. “A successful clinical trial of Ocelot would define a new world of hope for difficult PAD cases. The prospect of a new device and procedure that could help us save limbs is exciting for us at CVI.”
Elias Kassab, M.D., Cardiovascular Disease & Interventional Cardiology will also join the DMC team as a sub-investigator in this clinical trial.
PAD, affecting between eight and 12 million adults in the U.S. alone, is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. Because some blockages can become so severe and difficult to penetrate with traditional catheters, patients (unaware of other options) often resort to undergo extremely invasive bypass surgeries that result in even higher health risks and lengthy, painful recoveries. Patients over 50 often face amputation, the worst-case scenario associated with PAD.
Ocelot is the first-ever Chronic Total Occlusion crossing catheter that can access exact regions of the peripheral vasculature where the blockages occur, while simultaneously providing physicians with visualization for real-time navigation during an intervention.
Connect II trial procedures using Ocelot are minimally invasive and designed to allow patients to leave the hospital within hours, and return to normal activities within a few days.