New sirolimus balloon takes on paclitaxel in leg artery showdown
NCT ID NCT07359807
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two drug-coated balloons for treating narrowed or blocked arteries in the leg. The experimental balloon uses sirolimus, a drug that stops cells from growing and blocking the artery again, while the standard balloon uses paclitaxel. About 478 people with leg artery disease will be randomly assigned to one of the two balloons. The main goal is to see if the sirolimus balloon keeps arteries open just as well as the paclitaxel balloon after one year, with fewer complications.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- sirolimus (drug-coated balloon)
- What this could lead to
- If it works, this could offer a better option for opening blocked leg arteries, potentially reducing the need for repeat procedures.
- What could go wrong
- This is an early-to-mid-stage trial (Phase 2/3) with 478 participants, so results may not apply to everyone. The sirolimus balloon might not be as effective or safe as the standard paclitaxel balloon.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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.
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