The New York Presbyterian Hospital (NYPH) Division of Vascular Surgery is one of a select group of institutions around the country participating in a novel clinical trial to study the effect of drug therapy on atherosclerotic plaque in the arteries of the leg.
The trial, called LEAP (Lower Extremity Atherosclerotic Plaque Excision), aims to evaluate the biologic profile of plaque (a fatty blockage) collected from patients treated for Peripheral Artery Disease (PAD) with the SilverHawk™ Plaque Excision System. In the LEAP study, plaque removed from patients' leg arteries will be used for research aimed at identifying new indicators (or "biomarkers") of atherosclerotic disease progression. Identifying new biomarkers in plaque, may provide insight on cardiovascular disease and accelerate development of treatments for this widespread health issue. The LEAP trial is sponsored by FoxHollow Technologies, Inc., manufacturer of the SilverHawk System, in collaboration with Merck & Co., Inc.
PAD is a disease that affects over 12 million people in the United States. Similar to cardiovascular disease, PAD is caused by the buildup of fat and cholesterol, known as plaque, which disrupts normal blood flow to arteries in the vascular system. Symptoms of the disease often include severe pain, numbness, tingling or weakness in the leg. Leg pain, known as claudication, can be so extreme that patients often have difficulty walking short distances.
The Division of Vascular Surgery at NYPH is treating patients suffering from PAD with the SilverHawk Plaque Excision System, a device that uses a tiny rotating blade to shave away large volumes of plaque from inside leg arteries and remove it from the patient's body. Successful removal of this plaque improves blood flow to the leg and foot, relieving leg pain and in some cases, avoids limb threatening amputation.
The LEAP study involves patients who have arterial blockages in both their legs. Patients enrolled in the LEAP study will undergo SilverHawk plaque excision in one leg, receive one of the study drugs or a placebo for a period of time, and then undergo plaque excision in the other leg.
"LEAP is the first study of its kind and NYPH is proud to be a part of the research process," said Principal Investigator, James McKinsey, MD. "We are currently using the SilverHawk device to restore blood flow to the legs and have seen very good results with it for our patients," Dr McKinsey added.
FoxHollow Technologies, the study's sponsor, is working with Merck & Co., Inc., which has a collaborative research agreement with FoxHollow to study atherosclerotic plaque samples collected by FoxHollow. Merck will use the plaque to search for novel biomarkers that ultimately may enable physicians to understand and treat each patient's vascular disease on the basis of the patient's own biological profile.
