Jersey Shore University Medical Center Enrolling Patients in a Clinical Trial Treating Coronary Artery Disease

The academic medical center is the only hospital in New Jersey participating in the trial.

Cardiovascular experts at Hackensack Meridian Jersey Shore University Medical Center are enrolling eligible patients in Boston Scientific’s AGENT IDE clinical trial to treat in-stent restenosis (ISR), following a previous implantation of a coronary stent, through angioplasty. The academic medical center is the only hospital in New Jersey participating in the trial.

Coronary artery disease is primarily caused by the buildup of fat deposits or plaques that constrict the arteries supplying the heart with blood. Angioplasty, also known as percutaneous coronary intervention (PCI), is used to treat the disease. During PCI, cardiologists open clogged heart arteries with inflation of a balloon and placement of a stent, expanding and supporting the artery’s wall to improve blood flow to the heart. The percutaneous coronary intervention procedure can be used to treat a heart attack or relieve symptoms of coronary artery disease including chest pain and shortness of breath.

“Some people experience ISR after receiving a stent. It’s a gradual re-narrowing of the stented artery,” said Matthew Saybolt, M.D., FACC, Structural Heart Disease Program director, Jersey Shore University Medical Center. “This causes a recurrence of the symptoms of angina such as chest pain, shortness of breath and risk of heart attack.” ISR is currently treated by cardiologists through an additional angioplasty procedure utilizing a balloon to reopen the narrowed area again, often followed by placement of another stent.

AGENT IDE is a drug coated balloon, rather than the standard uncoated balloon, which includes a medication designed to prevent the artery from re-narrowing in the future. “There are many circumstances where we choose to not place another layer of stent in a patient’s artery and we restore flow with a balloon only. However, future re-narrowing remains a risk. This trial will determine if the AGENT IDE balloon is more effective in addressing ISR then a standard plain balloon, ultimately providing a more personalized solution for some patients and permanently preventing recurrence of their coronary artery blockage.”

This is a randomized study. There are a set of requirements that patients will need to follow in order to participate. Individuals who have received PCI and are experiencing chest pain or other symptoms should speak to their physician. If they are diagnosed with ISR and are interested in participating in the clinical trial, they should call the site Principal Investigator, Dr. Saybolt, for a consultation at 732-663-0300 or their physician can contact our clinical research coordinator Lynda Argenzio at 732-776-2953. (Caution: Investigational Device. Limited by Federal [or U.S.] law to investigational use only. Not available for sale.)

For more than 10 years, Jersey Shore University Medical Center has been one of the leading hospitals in the state in performing diagnostic and interventional cardiac procedures. “This wealth of experience has enabled our cardiovascular experts the ability to offer clinical trials like this and other novel techniques and procedures benefiting our patients,” said Vito Buccellato, MPA, LNHA, president and chief hospital executive, Jersey Shore University Medical Center.

In 2021, the academic medical center launched a $45 million invasive cardiovascular expansion project to create a dedicated, comprehensive cardiovascular suite, adding the latest technological upgrades. “We are providing our specialists with leading-edge tools to enhance our cardiovascular services,” said Kenneth N. Sable, M.D., MBA, FACEP, regional president, Southern Market, Hackensack Meridian Health. “At the same time we are creating a centralized, convenient space to improve the experiences of our patients and their loved ones.”

For information about Hackensack Meridian Health and Jersey Shore University Medical Center’s cardiovascular services, visit https://www.hackensackmeridianhealth.org/en/Services/Heart-Care For a free physician referral, call 844-HMH-WELL.