Balloon vs stent: which works best for clogged leg arteries?
NCT ID NCT07277218
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study compares two treatments for when a leg artery stent narrows again (in-stent restenosis). About 578 patients will receive either a drug-coated balloon or a drug-eluting stent, both of which release medication to keep the artery open. The goal is to see which approach reduces the need for repeat procedures over two years, helping doctors make better treatment decisions.
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 and paclitaxel-eluting stent
- What this could lead to
- If this study shows one treatment is clearly better, it could help doctors choose the most effective option for patients whose leg stents have narrowed again, reducing the need for repeat procedures.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be influenced by how doctors choose treatments. It is also early-stage and may not apply to all patients.
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 600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
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
Adults with symptomatic Rutherford category 2-5 femoropopliteal in-stent restenosis undergoing clinically indicated endovascular treatment at participating tertiary vascular centers in China. Potentially eligible patients will be screened consecutively. Treatment is selected by the treating physician as part of routine clinical care and is not assigned by the research protocol. The primary comparative cohort includes patients for whom both DCB-first and Eluvia-first strategies remain clinically feasible after lesion preparation.
- 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: Age \>18 years. Willing and able to provide written informed consent. Rutherford Clinical Category 2-5. Angiographically confirmed ≥50% stenosis or occlusion within a previously implanted superficial femoral or proximal popliteal artery stent more than 30 days after implantation. The target lesion is within the previously stented segment or extends no more than 3 cm proximally or distally beyond the prior stent. Total target lesion length ≤30 cm. At least one patent below-the-knee runoff vessel. Willing and able to complete follow-up through 24 months. After lesion preparation, both the DCB-first and Eluvia-first strategies remain clinically feasible. Exclusion Criteria: Pregnancy or lactation. Rutherford Clinical Category 0 or 6. Target lesion stenosis \<50%. Target lesion length \>30 cm. Severe calcification precluding endovascular treatment. Acute limb ischemia or acute thrombosis of the target limb. Untreated hemodynamically significant aorto-iliac inflow disease. Cerebrovascular accident within 60 days before the index procedure. Contraindication to required antiplatelet or anticoagulant therapy. Inability or unwillingness to provide informed consent. Life expectancy \<2 years or another factor making completion of follow-up unlikely. Persistent post-preparation anatomy that mandates one treatment strategy and therefore eliminates clinical equipoise.
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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 official record
ClinicalTrials.gov lists the study team's own contact details, including names. 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.