New stent could save limbs in critical leg artery disease
NCT ID NCT06122974
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial compares a new drug-coated temporary stent to standard balloon angioplasty for treating critical limb ischemia, a severe form of peripheral artery disease that can lead to amputation. The stent delivers sirolimus to prevent re-narrowing and is removed after treatment. About 518 participants will be followed for safety and effectiveness, including limb salvage and artery patency.
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 temporary stent
- 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 results yet. The device may not outperform standard balloon angioplasty, and risks include bleeding, infection, or vessel damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for CRITICAL LIMB ISCHEMIA are added.
By submitting, you agree to our Terms of use
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple thermal camera spot blood flow changes in leg arteries?
- Can Metal-Stripping infusions save diabetic limbs and hearts?
- Heat therapy for leg pain study pulled before starting
- New dissolving scaffold could save legs from amputation
- New imaging tool may predict leg amputation risk
- Music as medicine: simple tunes may soothe wound pain in artery disease