Dissolvable stent could save legs from amputation

NCT ID NCT06071429

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new type of stent that slowly dissolves and releases medication to keep leg arteries open. It is for people with chronic limb-threatening ischemia, a serious condition where blocked arteries can lead to amputation. About 300 participants will be randomly assigned to receive either this new stent or standard balloon angioplasty. The goal is to see if the stent helps save limbs and keeps arteries open longer.

What this could mean

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

Active substance

Sirolimus-eluting bioresorbable scaffold (a dissolvable stent that releases medication to keep arteries open)

What this could lead to

If it works, this could offer a better treatment option for people with severe leg artery disease, potentially reducing the need for amputation or repeat procedures.

What could go wrong

This is an early-stage trial with no phase designation, so results are uncertain. The device may not outperform standard balloon angioplasty, and risks include artery re-blockage or complications from the procedure.

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.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • CUMC/NYP

    RECRUITING

    New York, New York, 10032, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Staten Island University Hospital - Northwell Health

    RECRUITING

    Staten Island, New York, 10305, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact