New balloon treatment could save legs from amputation

NCT ID NCT05620095

Recruiting now Disease control Sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 1,000 people with severe leg artery disease (chronic limb-threatening ischemia) who are getting a drug-coated balloon to open blocked arteries below the knee. The balloon releases a drug (paclitaxel) to help keep the artery open. Researchers want to see if this treatment improves blood flow and reduces the need for repeat procedures or amputation over one year.

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
What this could lead to: If successful, this could confirm that drug-coated balloons are a safe and effective way to treat blocked leg arteries below the knee, potentially reducing the need for amputation.
What could go wrong: This is an observational registry, not a randomized trial, so results may be less definitive. The drug coating (paclitaxel) has raised some safety concerns in past studies, and long-term risks are still being studied.

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.

arteriosclerosis disorder Chronic Limb-Threatening Ischemia limb ischemia peripheral arterial disease

As listed by the trial registrant

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

ARTERIOSCLEROSIS CHRONIC LIMB-THREATENING ISCHEMIA PERIPHERAL ARTERY DISEASE

Contacts and locations

Locations

Hangzhou First People's hospital of Medical College of Zhejiang University
RECRUITING

Hangzhou, Zhejiang, China
Hospital of Chengdu University of Traditional Chinese Medicine
RECRUITING

Chengdu, Sichuan, China
Huashan Hospital, Fudan University
RECRUITING

Shanghai, Shanghai Municipality, China
Qingdao Haici hospital affiliated to Qingdao University
RECRUITING

Qingdao, Shandong, China
Renji Hospital of Shanghai Jiaotong University
RECRUITING

Shanghai, Shanghai Municipality, China
Xuanwu Hospital Capital Medical University
RECRUITING

Beijing, Beijing Municipality, China
Zhongshan Hospital of Fudan University
RECRUITING

Shanghai, Shanghai Municipality, China
Zibo Feng
RECRUITING

Wuhan, Hubei, 430000, China
the First Affiliated hospital of Medicine College of Zhejiang University
RECRUITING

Hangzhou, Zhejiang, China
the second Affiliated Hospital of Medical College of Suzhou University
RECRUITING

Suzhou, Jiangsu, China

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