A unique approach using a special drug-coated angioplasty balloon is now available through a clinical trial at PinnacleHealth Harrisburg Hospital for patients with blocked leg (femoral) arteries.
Peripheral arterial disease (PAD)
is one of the most common vascular diseases and occurs when leg arteries become narrowed or blocked by plaque and compromise blood flow. This condition can result in severe pain, limited physical mobility and non-healing leg ulcers, and it can potentially lead to amputation. PAD currently affects an estimated 27 million adults in North America and Europe.
When PAD causes symptoms in patients, blockages may need to be treated to restore blood flow to the legs and feet. Treatment options include angioplasty, a procedure in which a balloon catheter is delivered to the blockage and the balloon expanded to re-open the blood vessel. Re-blockage following an angioplasty remains a challenge and can occur in up to 50% of patients within 12 months of treatment, depending on the length and complexity of the blockage.
William Bachinsky, MD, FACC, FSCAI
, Medical Director, Vascular Services, PinnacleHealth Cardiovascular Institute, serves as the hospital’s principal investigator for the ILLUMENATE Pivotal trial testing a new angioplasty balloon. "Covidien’s Stellarex™ drug-coated peripheral angioplasty balloon provides the same mechanical effect of opening the vessel with the added advantage of drug delivery. When expanded, the balloon also rapidly deposits the drug paclitaxel into the vessel wall to inhibit re-blockage," said Dr. Bachinsky. "This treatment is designed with the potential to lengthen the clinical durability of angioplasty treatment, while leaving nothing behind (e.g., stent) in the blood vessel. We are fortunate to have access to this cutting edge technology right here in Harrisburg."
Enrolling up to 360 patients with femoral (leg) artery blockages in hospitals in the U.S., the study will compare the Covidien device to the standard treatment in head-to-head trial. Dr. Bachinsky and his team enrolled the first patient into the trial in Pennsylvania and the third in the U.S. on August 1, 2013.
The procedure is performed in one of five cardiac catheterization laboratories at PinnacleHealth Harrisburg Hospital. Each features advanced technology for the diagnosis and treatment of heart and vascular conditions, both emergency and elective, including high-resolution video screens and x-ray machines that provide enlarged pictures of the blocked areas in patients’ arteries, making data more accurate and accessible. PinnacleHealth Harrisburg Hospital cardiac cath labs are staffed with expert cardiologists and specialized cardiology-based nursing and support staff, all committed to providing patients with the highest quality care.
About PinnacleHealth System
PinnacleHealth is a pioneer not-for-profit healthcare system dedicated to providing and improving the health and quality of life for the people of Central Pennsylvania since 1873. A proven leader in medical innovation, PinnacleHealth offers a wide range of services from primary care to the most complex surgeries and Magnet recognition for nursing excellence. The healthcare network includes four campuses (Community, West Shore, Harrisburg and Polyclinic). The West Shore Hospital will open in Hampden Township in 2014. The five-story hospital will include 108 beds with an emergency department, medical/surgical care, cardiology, orthopedics, chronic disease management, and private patient rooms. Medical services, including family practice, imaging, outpatient surgery and oncology are offered at multiple locations throughout the region. For a complete list of services, visit our website at www.pinnaclehealth.org