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Main Line Health tops list of enrollment sites for one arm of peripheral artery disease treatment study

Main Line Health December 18, 2018 Research News

Main Line Health has enrolled the highest number of patients in the observational arm of the Disrupt PAD III clinical trial. To date, 60 patients with femoropopliteal disease have been enrolled in the international study of the Shockwave Medical Peripheral Lithoplasty® System, which is an FDA-approved balloon catheter that, once inserted in the calcified vessel, emits pulses that gently break up the plaque. This allows subsequent dilation of the peripheral artery stenosis using lower balloon pressure, and hopefully more effective expansion without as many dissections.

Additionally, Main Line Health has enrolled 11 patients in the randomized study section of this trial, although that arm has been put on hold temporarily while the device undergoes an upgrade to offer more energy delivery per pulse and more pulses per treatment. William Gray, MD, system chief of the cardiovascular division at Main Line Health, is the national principle investigator for this trial.

“We are very pleased to be the leading site nationwide among 21 medical centers currently using the Shockwave system,” said Sarang S. Mangalmurti, MD, an interventional cardiologist at Bryn Mawr Hospital and Main Line Health’s principal investigator on the trial. “This minimally invasive novel treatment may improve angioplasty results in patients with complex peripheral vascular disease and reduce the need for surgical bypass.”

Main Line Health has been enrolling patients in the observational study for almost one year and in the randomized study since June 2017. Patients who did not meet the inclusion/exclusion criteria for the randomized study were enrolled in the observational study. That said, all patients in the clinical trial were treated with the Shockwave system. The objective of the observational study is to assess the real-world acute performance of the device.

Lynn Sher, MBA, clinical research coordinator for the study, noted, “Offering this option to our patients enables Main Line Health to stay at the leading edge of treatments for those diagnosed with stenosis of the peripheral arteries.”

She added that Main Line Health soon will be recruiting patients for another study of the Shockwave device, this time in patients with complex coronary artery disease.

Clinicians interested in learning more about the Disrupt PAD III study, which is taking place at Bryn Mawr Hospital and Lankenau Medical Center, can read more at mainlinehealth.org/research/clinical-trials/disrupt-pad-iii.

About Main Line Health

Founded in 1985,Main Line Health is a not-for-profit health system serving portions of Philadelphia and its western suburbs. Main Line Health’s commitment—to deliver advanced medicine to treat and cure disease while also playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to keep our community and ourselves well ahead. A team of more than 10,000 employees and 2,000 physicians care for patients throughout the Main Line Health system.

At Main Line Health’s core are four of the region’s most respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s recognized facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare,one of the region’s largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect and inclusion and has proudly embraced the American Hospital Association’s #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help our community stay healthy.

About Lankenau Institute for Medical Research

Lankenau Institute for Medical Research (LIMR) is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center and is part of Main Line Health. Founded in 1927, LIMR’s mission is to improve human health and well-being. Faculty and staff are devoted to advancing innovative new approaches to formidable medical challenges, including cancer, cardiovascular disease, gastrointestinal disorders and autoimmune diseases, such as diabetes and arthritis. LIMR’s principal investigators conduct basic, preclinical and translational research, using their findings to explore ways to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians.