New balloon treatment versus stent for blocked heart arteries

Plain-English translation of NCT06959524 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated August 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing a new treatment called the AGENT drug-coated balloon, which is a special balloon that delivers medication as it opens up blocked heart arteries. Researchers want to see whether this medication-coated balloon works as well as or better than traditional stent placement (a metal mesh tube that holds arteries open). The study will compare these two approaches in different types of blockages—small vessels, complex splits in arteries, and longer blockages.

Currently, stents are the standard treatment for most blocked heart arteries, but they can sometimes cause problems like restenosis (the artery narrowing again) or limiting future treatment options. This trial is exploring whether this medication-coated balloon could be an effective alternative that avoids some of these complications.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have a newly formed blockage in a native heart artery that needs treatment
your blockage is severe enough to cause symptoms (more than 50% narrowed) or is very severe without symptoms (more than 70% narrowed)
you are willing to attend all follow-up visits over the next 12 months
if you are a woman who can become pregnant, you agree to use reliable birth control for 12 months after the procedure

You likely don't qualify if…

you have a serious illness like cancer or severe heart failure that may shorten your life to less than one year
you have a current substance abuse problem or active unstable heart attack with rising heart damage markers
you have had a heart procedure in the last 30 days or have planned heart surgery after this procedure
you are allergic to paclitaxel (the medication on the balloon) or contrast dye that cannot be safely managed
you have severe kidney disease, very low platelet counts, or cannot tolerate stopping blood thinners

What participation looks like

If you join this trial, you will be randomly assigned to receive either the new AGENT drug-coated balloon or standard stent treatment during your heart procedure. The procedure itself is similar to standard care—your doctor will use a catheter to reach the blocked artery and open it. After the procedure, you will return for follow-up visits at regular intervals to have imaging tests (like ultrasound of your heart) and blood work to monitor how well the treatment is working over 12 months.

AI-generated summary from trial data · Aug 2, 2026 · Not medical advice

Trial locations(67 sites)

United States

Scripps Memorial Hospital, La Jolla, California

USC Medical Center, Los Angeles, California

Cedars - Sinai Medical Center, Los Angeles, California

University of California San Francisco, San Francisco, California

Stanford University Medical Center, Stanford, California