New balloon treatment aims to keep leg arteries open longer
NCT ID NCT07425171
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study will test a special balloon coated with the drug paclitaxel to treat long blockages in the leg arteries. About 300 people with severe leg pain or wounds will receive the balloon treatment during a standard angioplasty procedure. Researchers will track how well the arteries stay open and whether patients need additional procedures over the next 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 provide a reliable treatment option for long blockages in leg arteries, reducing the need for repeat procedures and improving blood flow.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less definitive. The balloon uses a drug (paclitaxel) which has been linked to a small increased risk of death in some prior studies, though this is still debated.
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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- 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.
Who is studied
Patients with long femoropopliteal lesions who underwent percutaneous angioplasty using GENOSS PCB
- Ages
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19 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\> Enrollment in the study was limited to patients who met the following inclusion criteria: 1. Subject was ≥19 years of age. 2. Subject had target limb Rutherford classification 2, 3, 4 or 5. 3. Subjects with a stenosis of 70% or greater in the femoropopliteal artery. 4. Subjects with a stenotic or occlusive lesion measuring ≥150 mm in total length. (Multiple adjacent lesions separated by less than 3 cm from angiographically healthy segments are treated as a single lesion.) 5. Subjects with a reference vessel diameter of ≥4 mm but ≤7 mm. 6. Subject provided written informed consent and was willing to comply with the study follow-up requirements. \<Exclusion criteria\> Patients were not permitted to enroll in the study if they met any of the following exclusion criteria: 1. Subjects was allergic to paclitaxel. 2. Subjects with contraindications or hypersensitivity to antiplatelet therapy. 3. Subject had life expectancy of less than 2 years. 4. Those who have undergone vascular surgery on the target lesion within the past 6 weeks. 5. Those who have in-stent restenosis (ISR) on the target lesion. 6. Those who have non-arteriosclerotic vascular disease, such as an aneurysm or vasculitis, on the target lesion. 7. Women who were pregnant, breast-feeding or intended to become pregnant. 8. Those who cannot perform pre-dilatation or who fail to apply the device, making it difficult to apply the device. 9. Those who have a Grade D or higher vascular dissection restricting blood flow after pre-dilatation or who require stent placement. 10. Those who, in the investigator's judgment, are not suitable for this study or may increase the risks associated with participation in the 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
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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Ajou University Hospital
RECRUITINGSuwon, Gyeonggi-do, 16499, South Korea
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