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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Bites and Stings Constriction, Pathologic peripheral arterial disease

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

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