New balloon could open blocked heart arteries without a stent

NCT ID NCT07444957

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a special balloon coated with the drug sirolimus to treat blocked heart arteries. The balloon is inflated inside the artery to push the blockage aside and release the drug, which helps prevent the artery from narrowing again. Researchers will follow over 1,100 patients for up to 3 years to see if this approach is safe and effective in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
sirolimus-coated balloon (a balloon catheter that delivers the drug sirolimus to open blocked arteries)
What this could lead to
If successful, this could provide a safe and effective way to treat coronary artery disease without leaving a permanent stent, potentially reducing long-term complications.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The balloon may not work as well as stents in all patients, and there are risks like artery damage or re-narrowing.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Álvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

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