New balloon coated with drug could save limbs in severe artery disease
NCT ID NCT06330493
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a paclitaxel-coated balloon to a standard balloon for opening blocked arteries below the knee in people with chronic limb-threatening ischemia, a serious condition that can lead to amputation. About 288 participants will be randomly assigned to one of the two treatments. The goal is to see if the drug-coated balloon is better at keeping arteries open and preventing major amputations at 6 months, while being as safe as the standard balloon.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
paclitaxel-coated balloon catheter
What this could lead to
If successful, this could offer a better treatment option to save limbs and improve blood flow in patients with severe leg artery disease.
What could go wrong
This is a mid-stage trial with 288 participants, so results may not apply to everyone. The drug coating may not work better than standard treatment, and there are risks like restenosis or need for repeat procedures.
Disclaimer
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
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AZ Sint Blasius Hospital
RECRUITINGDendermonde, Belgium
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American Endovascular and Amputation Prevention (AEAP)
RECRUITINGOrange, New Jersey, 92868, United States
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Ballad Health CVA Heart Institute
RECRUITINGKingsport, Tennessee, 37660, United States
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Baylor Scott & White Research Institute (BSW)
RECRUITINGFort Worth, Texas, 76104, United States
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California Cardiovascular Consultants and Medical Associates
RECRUITINGFremont, California, 94545, United States
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Clements University Hospital (UTSW)
RECRUITINGDallas, Texas, 75390, United States
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195-0001, United States
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Columbia University/NYPH
RECRUITINGNew York, New York, 10032, United States
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Cornell University
RECRUITINGNew York, New York, 10065, United States
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First Coast Cardiovascular Institute
RECRUITINGJacksonville, Florida, 32255, United States
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John Muir Health
RECRUITINGConcord, California, 94520, United States
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Medical University Graz
RECRUITINGGraz, 8036, Austria
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Miami Vascular Center
RECRUITINGHialeah, Florida, 33012, United States
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Midwest Cardiovascular Research Foundation
WITHDRAWNDavenport, Iowa, 52801, United States
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Miriam Hospital
RECRUITINGProvidence, Rhode Island, 02906, United States
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North Dallas Research Associates (NDRA)
ACTIVE_NOT_RECRUITINGMcKinney, Texas, 75069, United States
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South Charlotte General & Vascular Surgery
RECRUITINGCharlotte, North Carolina, 28278, United States
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Sunrise Vascular
RECRUITINGDanville, Virginia, 24541, United States
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Yale School of Medicine
RECRUITINGNew Haven, Connecticut, 06519, United States
Contact Email: •••••@•••••
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