Advancing Limb Preservation

Novel therapies addressing critical limb ischemia available at UH Harrington Heart & Vascular Institute

UH Harrington Heart & Vascular Institute - Summer 2018

Vikram Kashyap, MD


Chief, Division of Vascular Surgery and Endovascular Therapy, University Hospitals Cleveland Medical Center, Co-Director, Vascular Center, University Hospitals Harrington Heart & Vascular Institute Alan H. Markowitz, MD, Master Clinician for Cardiac and Vascular Surgery; Professor of Surgery, Case Western Reserve University School of Medicine

Mehdi Shishehbor, DO, MPH, PhD


Director, Interventional Cardiovascular Center, and Co-Director, Vascular Center, University Hospitals Harrington Heart & Vascular Institute; Professor of Medicine, Case Western Reserve University School of Medicine

For patients with critical limb ischemia (CLI), it can often seem that there are no good treatment options. Studies show that some patients, in fact, undergo an amputation without ever having a vascular assessment.

At University Hospitals Cleveland Medical Center, interventional cardiologist Mehdi Shishehbor, DO, MPH, PhD, is aiming to disrupt this status quo. He is national principal investigator for four different clinical trials aimed at reducing leg amputation, giving UH patients important access to novel CLI therapies.

Perhaps the most unusual study of the four is one exploring whether radial artery access through the patient’s wrist, now commonly used in heart catheterizations, can be safely and effectively employed to address vascular blockages in the legs.

“We are the first institution in the world to start a program like this,” says Dr. Shishehbor, who is Director of the Interventional Cardiovascular Center and Co-Director of the Vascular Center at UH Harrington Heart & Vascular Institute. “In the heart, that has become the normal path. The last five to 10 years have shown us that when you treat patients from the wrist, it is less risky, it is associated with less bleeding, it is associated with less cost, and patient satisfaction and the quality of the procedure are higher than if you do the procedure from the groin. We have been working with a device manufacturer to see if we can move the field forward in the area of lower extremities. It’s a series of devices that are able to complete a procedure that is currently being done through the groin.”

Also in the realm of investigational devices is the “Chocolate” drug-coated balloon catheter, manufactured by QT Vascular. Dr. Shishehbor is national co-principal investigator of the “Chocolate Touch” clinical trial evaluating whether this second-generation device is superior to the older Lutonix model. The primary endpoint of the trial is “true drug-coated balloon success,” defined as the patient achieving primary patency without bail-out stenting.

“We are excited to enroll patients in this worldwide study evaluating Chocolate, a second-generation drug-coated balloon,” Dr. Shishehbor says. “This first-of-its-kind trial will help guide physicians as they choose the best drug-coated balloon for their patients.”

At the American College of Cardiology meeting last March, Dr. Shishehbor presented data on another CLI research priority – biologic therapy. The STOP-PAD trial evaluated the effectiveness of JVS-100, manufactured by Juventas Therapeutics.

“We were injecting biologic therapy into the foot as an adjunctive therapy to the revascularization to see if we could heal those wounds in a more timely fashion,” Dr. Shishehbor says. “What this compound does is attract the natural angiogenic factors to the site of the injection. If you have a wound in your foot and we inject this in the foot, it will excite and direct the naturally occurring angiogenic factors in the body to the site of injury. By doing so, we hope that we build new small blood vessels to improve perfusion.”

Initial results from STOP-PAD show no effect on wound healing from JVS-100, measured at three months after the initial dose. However, Dr. Shishehbor says it’s too soon to close the book on the product.

“We are very much looking forward to the six-month data,” he says. “Based on those results, we will determine whether we will investigate this biologic therapy in a longer study, or perhaps consider studying a combination therapy that involves more than one biologic therapy.”

In the meantime, Dr. Shishehbor is turning his attention to another novel CLI therapy – LimFlow.

UH is one of six facilities in the U.S. participating in a pilot study to investigate the safety, effectiveness and feasibility of the LimFlow stent graft system for creating an AV fistula in the below-the-knee vascular system. An endovascular, minimally invasive approach for the treatment of CLI, it will be studied in patients ineligible for conventional endovascular or surgical limb salvage procedures. Two patients, including a compassionate use patient, have already been treated with this system at UH.

“I’m really excited about it because it gives us the opportunity to treat patients that would otherwise undergo major amputation,” Dr. Shishehbor says. “It’s so novel and so new and such a big deal.”


For more information about novel treatments for CLI available at UH Harrington Heart & Vascular Institute or to refer a patient, please call X.