New balloon could keep leg arteries open longer
NCT ID NCT07187128
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a drug-coated balloon to treat blockages in the leg's main artery. About 150 people with moderate to severe symptoms will receive the balloon treatment. The goal is to see if it keeps arteries open for at least 12 months and reduces the need for further procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- drug-coated balloon catheter
- What this could lead to
- If successful, this could provide a more effective way to keep leg arteries open after angioplasty, reducing the need for repeat procedures.
- What could go wrong
- This is a post-market study, so the device is already approved. However, it may not work for all patients, and risks include artery damage or re-blockage.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- 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. Aged 18 to 85 years, gender not restricted; 2. Rutherford grade 2 to 5 3. Target lesions located in the superficial femoral artery (SFA) and/or proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics: * Diameter stenosis ≥70% by visual estimation or * Chronic total occlusion (CTO) 4. At least one native below-the-knee artery supplying the foot on the affected side preoperatively; 5. The guidewire can successfully pass through the target lesion site within the vascular lumen; 6. Agree to participate in this clinical study and voluntarily sign the informed consent form. Exclusion Criteria: 1. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment 2. Type D or higher dissection occurring after target lesion predilation; 3. Residual diameter stenosis \>50% following target lesion predilation; 4. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.; 5. Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators; 6. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel/structural analogs, or contrast agents; 7. Patients currently undergoing dialysis or immunosuppressive therapy; 8. Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis; 9. History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure; 10. Pregnancy or lactation women; 11. Currently participation in other drug/medical device clinical trials without completion; 12. Patients deemed by the investigator to be unsuitable for participation in this study.
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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
2 sites. 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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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chognqing, China
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China