News | December 28, 2011

Good Samaritan Hospital Investigates Drug-Eluting Balloons to Treat Peripheral Arterial Disease

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:,

Related Content

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Clinical Study | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Clinical Study | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Clinical Study | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init