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New balloon treatment could save legs from amputation

NCT ID NCT05620095

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients suffered with Chronic Limb Theratening Ischemia and with significant infrapopliteal artery lesions.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Rutherford grade 4-6. 2. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up. 3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries \>20 mm. Lesions should not extend beyond the ankle joint. 4. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow. 5. At least one of the infrapopliteal arteries received a drug-coated balloon. 6. For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%. 7. In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention. 8. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time. 9. Life expectancy\> 24 months. Exclusion Criteria: 1. Blood flow was not successfully reestablished. 2. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment. 3. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc. 4. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months. 5. Pregnant and lactating women. 6. Patients with Berg's disease. 7. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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