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Dr. Mehran served as co-lead investigator on the groundbreaking "SELUTION4ISR Trial," with findings unveiled at the Transcatheter Cardiovascular Therapeutics Conference in 2025.

Credit: Mount Sinai Health System

A newly developed drug-coated balloon has shown results comparable to current standard treatments for patients experiencing coronary in-stent restenosis (ISR) who undergo repeat percutaneous coronary intervention (PCI). This important international study, led by a Mount Sinai investigator, could significantly influence treatment options for these patients.

Marking the first large-scale, U.S.-regulated randomized trial of its kind, researchers evaluated a balloon coated with the drug sirolimus against traditional ISR treatments such as additional stents and plain balloon angioplasty. This innovation offers a potentially safer and simpler method for those requiring further PCI procedures.

Key findings from the SELUTION4ISR Trial were highlighted during a Late Breaking Clinical Trial presentation on October 26 at the Transcatheter Cardiovascular Therapeutics event in San Francisco.

“We’ve demonstrated for the first time that a sirolimus-eluting balloon matches standard ISR care outcomes, without adding another stent layer,” explained Dr. Roxana Mehran, co-lead investigator and Director of Interventional Cardiovascular Research and Clinical Trials at the Icahn School of Medicine at Mount Sinai. “This approach simplifies treatment and gives new hope to patients struggling with multiple stents. It reflects a major step forward in managing ISR.”

ISR is a condition in which an artery narrows again after initially being opened through PCI. PCI is a minimally invasive procedure where doctors use a catheter to place a stent in a blocked coronary artery to restore blood flow.

The standard protocol for ISR includes inserting another drug-eluting stent or performing balloon angioplasty. This process adds layers of metal inside arteries and requires antiplatelet medication. Repeated stenting can complicate future interventions and raise risks like heart attacks due to recurrent blockage. One out of every ten PCI interventions in the U.S. addresses ISR, impacting thousands of patients annually.

Another option currently available involves drug-coated balloons using paclitaxel, especially for patients dealing with diabetes or high risk of bleeding. These are approved for clinical use and offer some respite from repeated metal implants.

This trial focused on a new type of drug-eluting balloon, the Selution Sustained Limus Release Balloon, which delivers sirolimus — a powerful drug that suppresses immune responses and blocks smooth muscle and inflammatory cell growth, both of which can cause restenosis.

The study included 418 people with ISR, each having one or two previous stent implants. Participants were randomly assigned in a single-blind, multicenter trial — 197 received the sirolimus-coated balloon, while 193 followed standard of care (80% underwent drug-eluting stent placement and 20% had plain balloon angioplasty). Researchers tracked how often treated lesions failed over the year following the procedure.

After one year, the difference in target lesion failure between the two groups was not significant — 16.2% for the sirolimus group and 13.5% for the standard care group. The number of patients needing another treatment at the target site was nearly the same: 12.7% versus 12.4%, respectively. Overall, the balloon matched traditional outcomes. While standard treatment slightly outperformed for patients with a single earlier stent, the sirolimus balloon performed better than plain angioplasty alone.

“This innovation may allow ISR patients to avoid having another metal stent placed,” said Dr. Mehran. “That could be particularly beneficial for those with several layers of stents already. These findings support the use of sirolimus-eluting balloons as an effective option in complicated ISR cases. Treatment selection can now be more precisely tailored to stent history and lesion details.”

Researchers are continuing to observe participants over five years to study long-term effectiveness. Further research will explore how the device performs with multiple prior stents and in smaller vessels. Additional evaluations will assess cost-efficiency and patient quality of life.

This research was financially supported by M.A. Med Alliance SA, a Cordis Company.

Mount Sinai: A Global Leader in Cardiovascular Medicine

The Mount Sinai Fuster Heart Hospital at The Mount Sinai Hospital is ranked No. 2 in the nation for cardiology and heart surgery by U.S. News & World Report®. It also holds the top spot in New York and is ranked No. 6 worldwide, as per Newsweek's "The World’s Best Specialized Hospitals."

Mount Sinai Health System is the largest academic medical network in New York City. It includes seven hospitals, a renowned medical school, and an extensive network of outpatient practices across the region. The health system aims to lead globally in education, research, and patient care, maintaining a strong emphasis on safety, quality, accessibility, equity, and value. Mount Sinai's network features roughly 9,000 primary and specialty care physicians, ten independent joint-venture centers throughout New York, Westchester, Long Island, and Florida, and 48 research and clinical institutes. The system and its hospitals consistently earn top rankings from both Newsweek and U.S. News & World Report.

Method of Research

Randomized controlled/clinical trial

Subject of Research

People