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New study observes best way to treat leg clots without major surgery

NCT ID NCT04861506

Knowledge-focused Sponsor: First People's Hospital of Hangzhou 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is tracking 400 people with acute or subacute blood clots in their legs to see how well endovascular treatments (minimally invasive procedures using catheters, balloons, stents, or clot-removal devices) work. The main goal is to see how many patients avoid amputation and serious complications like re-clotting or kidney failure within one month. The results will help doctors understand which techniques are safest and most effective for these patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endovascular treatment (procedure using catheters, balloons, stents, or clot-removal devices)
What this could lead to
If successful, this study could help doctors choose the safest and most effective endovascular technique for treating leg blood clots, potentially reducing amputations.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove one treatment is better than another. Results may vary by patient and surgeon skill.

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 400 people

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

Started

Apr 2021

Expected to finish

Dec 2025

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 with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.

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. Patients aged 18 years or older. 2. Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb. 3. Rutherford classification ranging from 3 to 5. 4. Successful guidewire passage through the lesion of the femoropopliteal artery lesion, followed by further endovascular treatment. There are no restrictions will be implemented on the methods used for guidewire passage through the target lesion. The presence of thrombus must be confirmed via angiography and/or DSA and must be associated with occlusions of the lower extremity or ISR. 5. Mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT) and/or percutaneous aspiration thrombectomy(PAT) and/or CDT (catheter-directed thrombolysis) performed for thrombus removal. 6. The lower extremity artery must have a healthy runoff of at least 10 cm above the ankle with at least one healthy dorsalis pedis artery, medial plantar artery, or lateral plantar artery connecting to the digital artery below the ankle. 7. Informed consent signed by patients. Exclusion criteria 1. Acute or subacute limb ischemia patients with Rutherford classification stage III. 2. Patients diagnosed with thromboangiitis obliterans. 3. Patients requring open surgery or hybrid operation after contrast radiography. 4. Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months. 5. Patients with known allergies to heparin, low molecular weight heparin, or contrast agents. 6. Patients at high risk for bleeding. 7. Pregnant or lactating women. 8. Patients with other conditions that may complicate study participation or significantly reduce life expectancy (\< 2 years), such as tumors, severe liver disease, and cardiac insufficiency. 9. Patients enrolled in other clinical studies within the past 3 months. 10. Patients unwilling or refusing to sign the informed consent form. \-

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Conditions

The condition(s) this trial relates to.

Thromboembolism thrombotic disease

As listed by the trial registrant

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

Efficacy, self Endovascular treatment Lower extremity problem Safety issues Thromboembolic disease

How to take part

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

  1. The places running it

    1 site. 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

  • Fan xin

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

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