Plaque removal plus balloon: better for leg artery blockages?
NCT ID NCT07406308
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to treat chronic blockages in the leg arteries: using a drug-coated balloon alone versus using the balloon along with a plaque-removal procedure (like laser or atherectomy). About 408 people with blocked leg arteries will be enrolled. The main goal is to see which approach keeps the artery open longer after one 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 show that adding plaque removal to balloon treatment improves long-term artery openness for people with leg artery blockages.
- What could go wrong
- This is a very early (Phase 1) trial, so results are uncertain. The study hasn't started recruiting yet, and the approach may not prove better than the standard balloon alone.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 408 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2028
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.
- Ages
-
18 to 85 years
- 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 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: * Subject age 18-85yrs. * Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form. * Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing. * Rutherford category 2-5. * Subject has atherosclerotic de novo, non-stented restenotic, or in-stent restenotic/occlusive lesions in the superficial femoral artery (SFA) and/or popliteal artery (P1 segment). * Patent inflow artery with stenosis \<30% by visual estimation (or by core lab assessment if available) and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis). * A guidewire has successfully traversed the target treatment segment. Exclusion Criteria: * Subject presents with acute arterial embolism or thrombosis requiring thrombectomy or thrombolysis for limb ischemia. * Subject has arterial occlusion caused by thromboangiitis obliterans (Buerger's disease) or other forms of immune-mediated vasculitis. * Subject has undergone surgery on the target vessel within the past 3 months, or has experienced repeated failures of endovascular therapy and is deemed unsuitable for further endovascular intervention. * Subject has an uncontrolled thrombophilia or hypercoagulable state. * Subject has a severe systemic disease (e.g., malignancy) with a life expectancy of less than 1 year. * Subject has contraindications or intolerance to antiplatelet/anticoagulant medications, such as aspirin, clopidogrel, or heparin. * Subject is pregnant or breastfeeding. * Subject meets one or more of the following conditions: chronic renal insufficiency (SCr ≥ 2.5 mg/dL) or on regular dialysis; cardiovascular or cerebrovascular surgery within the past 1 month; or severe sequelae from a major stroke. * Subject has a known allergy to nitinol alloy, paclitaxel, or contrast agents.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Femoropopliteal artery occlusion are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Peking Union Medical College Hospital
Beijing, 100730, China