New filter device aims to prevent blockages during leg artery surgery
NCT ID NCT07282301
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special filter device designed to catch debris during procedures that clear blockages in the leg arteries. The goal is to prevent small particles from traveling downstream and causing serious complications. About 150 adults with leg artery disease will be enrolled to see if the filter improves safety and outcomes.
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
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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 using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Age \> 18 years 2. Rutherford classification 2-5 3. Patients with chronic femoropopliteal obstruction or thromboembolism who require debulking prior to other endovascular treatments. 4. Patients who understand the purpose of this study, participate in the study voluntarily, sign the informed consent and are willing to receive follow-up visits 5. The guidewire needs to pass through the lesion 6. Life expectancy \>24 months 7. Moderate to severe calcified lesions confirmed by imaging 8. For patients who receive intervention in both lower extremities, they may be enrolled in order of time of endovascular therapy 9. For combined aortoiliac artery lesions, recanalization of blood flow through endoluminal reconstruction of the vessel without more than 50% residual stenosis. Exclusion Criteria: 1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment 2. Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc. 3. Patients who have been treated with drugs that interfere with this clinical trial or intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, etc., within the last 3 months; 4. Pregnant and lactating women 5. Patients who are unable or unwilling to participate in this trial 6. patients with Berger's disease 7. Patients who have undergone arterial bypass on the treated side
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Renji Hospital
RECRUITINGShanghai, Shanghai Municipality, 200217, China
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