December 28, 2011 – Good Samaritan Hospital in Los Angeles is participating in the Levant 2 clinical trial to investigate a potential new treatment option for people with peripheral artery disease (PAD). The clinical trial will help doctors determine whether a drug-coated angioplasty balloon will be more successful in keeping narrowed arteries open for longer compared to treatment with a non-coated standard angioplasty balloon.
An estimated 8 million Americans have peripheral artery disease, including the 12 to 20 percent of individuals older than age 60, according to the Centers for Disease Control. PAD is a disease in which plaque builds up in the arteries that carry blood to the head, organs and limbs. Plaque is made up of fat, cholesterol, calcium, fibrous tissue and other substances in the blood. When plaque builds up in the body's arteries, the condition is called atherosclerosis. Over time, plaque can harden and narrow the arteries, which eventually limits the flow of oxygen-rich blood to the organs and other parts of body.
PAD usually affects the arteries in the legs, but it can also affect arteries that carry blood from the heart to the head, arms, kidneys, and stomach. Many people who have PAD do not have any signs or symptoms. Others may experience difficulty when walking or climbing stairs. Physical exertion can cause pain, numbness, aching or heaviness in the leg muscles. Other symptoms may include cramping in the affected leg(s), in the buttocks, thighs, calves and feet.
Other clinical signs of PAD include:
- Weak or absent pulses in the legs or feet
- Sores or wounds on the toes, feet, or legs that heal slowly, poorly, or not at all
- A pale or bluish color to the skin
- Gangrene of the toes or feet
- A lower temperature in one leg compared to the other leg
- Poor nail growth on the toes and decreased hair growth on the legs
- Erectile dysfunction, especially among men who have diabetes
Treatment for PAD focuses on reducing symptoms, preventing further progression of the disease and in most cases, lifestyle changes, exercise and claudication medications that can help slow the progression or even reverse the symptoms of PAD.
"Restenosis or renarrowing of arteries in the legs has been the 'Achilles Heel' of peripheral vascular interventions despite recent technological advances in angioplasty balloons, vascular stents and atherectomy devices," said Guy Mayeda, M.D., an interventional cardiologist at Good Samaritan Hospital. "If the paclitaxal-coated balloon under investigation in the Levant 2 trial demonstrates an ability to significantly reduce arterial renarrowing, it could establish a very significant change in the treatment of peripheral artery disease for potentially millions of patients."
The Levant 2 trial involves utilization of a new drug-coated balloon in the treatment of narrowed arteries in the legs. Patients considered for enrollment in the clinical trial are screened using an ultrasound test to assess the degree of narrowing and blood flow to the legs.
For more information: www.Levant2.com, www.goodsam.org