FALL RIVER, Mass. – Southcoast Health Chief of Vascular Surgery Dr. Richard Pin and a team at the Heart and Vascular Center at Charlton Memorial Hospital became the first to enroll and treat a patient in the national LIFE-BTK randomized clinical trial PK sub-study, system officials announced today.

“We are honored to be part of this clinical trial,” says Dr. Pin. “It is an amazing achievement for a community health system to be asked to participate in a randomized clinical trial, and for Charlton to go above the pace that was expected in enrolling patients is testament to the hospital’s exceptional cardiovascular program. This trial serves a need for critical patients in the south coast region who would otherwise have limited options. I am proud of our team for their outstanding work to advance cardiovascular care in our community.”

The LIFE-BTK trial is designed to evaluate the Esprit™ BTK Drug-eluting Resorbable Scaffold for the treatment of below-the-knee artery stenosis in symptomatic critical limb ischemia (CLI) patients, evaluating it against Percutaneous Transluminal Angioplasty (PTA). Unlike other drug-eluting stents, the Esprit-BTK investigational device is not a permanent implant; it provides support to an artery immediately after a balloon angioplasty, preventing the vessel from reclosing. Once implanted, the scaffold delivers a drug over a few months to promote healing and keep the artery open before dissolving.

CLI is a severe form of Peripheral Arterial Disease (PAD) that can lead to amputation. It involvesthe narrowing or blockage of the peripheral arteries carrying blood from the heart to the legs and arms and is estimated to affect approximately two million people nationwide. This decreased blood flow to lower limbs and can lead to increased mortality rates and amputations if left untreated.

The PK sub-study takes the clinical trial a step further to evaluate the effectiveness of the drug everolimus by analyzing numerous blood samples taken at predetermined times. This sub-study is only planning to enroll 7 patients nationally due to the very limited inclusion criteria.   

“We are grateful to have had a patient willing to participate considering the number of blood draws that are required both at the hospital and for months thereafter,” says Debra Benevides, a Clinical Research Coordinator at Southcoast Health. “In this study, blood samples were collected every 15 minutes during the procedure and then at regular intervals over the next 60 days. Clinical trials are successful because of the patients who are willing to participate and donate their time.” The initial procedure was performed on February 10, 2022.

Charlton Memorial’s Heart and Vascular Center continues to be a regional leader in advanced cardiovascular services. “I want to congratulate Dr. Pin and his team once again for their outstanding work to provide advanced cardiovascular care to our patients,” says Dr. Peter Cohn, Physician in Chief of the Cardiovascular Care Center at Southcoast Health. “Participating in this randomized clinical trial sub-study demonstrates Southcoast Health’s commitment to bringing innovative technology and research to patients in our community.”  

More information about the Heart and Vascular Center at Charlton Memorial Hospital can be found here.