New balloon coated with drug could save limbs in severe artery disease

NCT ID NCT06330493

Recruiting now Disease control Sponsor: Acotec Scientific Co., Ltd Source: ClinicalTrials.gov ↗

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.

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

AZ Sint Blasius Hospital
RECRUITING

Dendermonde, Belgium
American Endovascular and Amputation Prevention (AEAP)
RECRUITING

Orange, New Jersey, 92868, United States
Ballad Health CVA Heart Institute
RECRUITING

Kingsport, Tennessee, 37660, United States
Baylor Scott & White Research Institute (BSW)
RECRUITING

Fort Worth, Texas, 76104, United States
California Cardiovascular Consultants and Medical Associates
RECRUITING

Fremont, California, 94545, United States
Clements University Hospital (UTSW)
RECRUITING

Dallas, Texas, 75390, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195-0001, United States
Columbia University/NYPH
RECRUITING

New York, New York, 10032, United States
Cornell University
RECRUITING

New York, New York, 10065, United States
First Coast Cardiovascular Institute
RECRUITING

Jacksonville, Florida, 32255, United States
John Muir Health
RECRUITING

Concord, California, 94520, United States
Medical University Graz
RECRUITING

Graz, 8036, Austria
Miami Vascular Center
RECRUITING

Hialeah, Florida, 33012, United States
Midwest Cardiovascular Research Foundation
WITHDRAWN

Davenport, Iowa, 52801, United States
Miriam Hospital
RECRUITING

Providence, Rhode Island, 02906, United States
North Dallas Research Associates (NDRA)
ACTIVE_NOT_RECRUITING

McKinney, Texas, 75069, United States
South Charlotte General & Vascular Surgery
RECRUITING

Charlotte, North Carolina, 28278, United States
Sunrise Vascular
RECRUITING

Danville, Virginia, 24541, United States
Yale School of Medicine
RECRUITING

New Haven, Connecticut, 06519, United States

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