Dissolvable stent could save legs from amputation

NCT ID NCT06071429

Recruiting now Disease control Sponsor: R3 Vascular Inc. Source: ClinicalTrials.gov ↗

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.

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.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

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

CHRONIC LIMB-THREATENING ISCHEMIA

Contacts and locations

Locations

CUMC/NYP
RECRUITING

New York, New York, 10032, United States
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
Staten Island University Hospital - Northwell Health
RECRUITING

Staten Island, New York, 10305, United States

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