Metal mesh stent aims to hold blocked leg veins open
NCT ID NCT07809204
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers at five hospitals in China are studying the Vflower venous stent system in about 310 adults with narrowed or blocked veins in the pelvis or thigh. These blockages can cause leg swelling, pain, varicose veins, skin changes, and non-healing ulcers. During a minimally invasive procedure, a doctor inflates a balloon to open the vein and places a metal mesh stent to keep it open. The study tracks whether the vein stays open at 12 months, along with symptom relief, repeat procedures, and complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vflower venous stent system, a self-expanding nitinol mesh tube placed after balloon angioplasty
- What this could lead to
- If the stent keeps veins open and eases leg swelling and pain, it could become a routine option for people with narrowed or blocked pelvic and thigh veins.
- What could go wrong
- This is an observational study, not a randomized comparison, so it cannot prove the stent works better than other treatments. Stents can clot, narrow again, or need repeat procedures, and results from five hospitals in China may not apply everywhere.
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 310 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
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
This is a single-cohort study population of approximately 310 adult patients (aged ≥18 years) with symptomatic iliofemoral vein stenosis (≥75%) or complete occlusion, with CEAP clinical classification C3-C6. The population includes patients presenting with chronic venous disease manifestations including lower limb edema, pain, heaviness, skin changes (pigmentation, eczema, lipodermatosclerosis), or active/healed venous ulcers. All enrolled patients are able to tolerate antiplatelet/anticoagulant therapy and willing to comply with all study procedures and scheduled follow-up visits at 1, 6, 12, and 24 months post-procedure.
- 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: * Inclusion Criteria 1. Age ≥18 years. 2. Symptomatic iliofemoral vein stenosis (≥75%) or complete occlusion, confirmed by imaging (duplex ultrasonography, CTV, MRV, or DSA). 3. CEAP clinical classification C3-C6. 4. Willing and able to provide written informed consent and comply with all study requirements, including scheduled follow-up visits. Exclusion Criteria: 1. Pregnancy or lactation. 2. Known hypersensitivity or contraindication to nitinol, contrast media, or antiplatelet/anticoagulant medications that cannot be managed. 3. Active systemic infection or untreated sepsis. 4. Life expectancy \<12 months due to non-venous comorbidities. 5. Inability to tolerate antiplatelet or anticoagulant therapy. 6. Concurrent enrollment in another investigational device or drug study. 7. Iliofemoral venous lesions not amenable to endovascular treatment as determined by the investigator.
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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 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.