3D eye for leg arteries: sharper view may boost treatment success
NCT ID NCT04434586
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares standard 2D X-ray imaging with a 3D imaging technique called OCT during leg artery procedures. About 166 adults with blocked leg arteries will be randomly assigned to one of two groups. The goal is to see if OCT helps doctors place stents and inflate balloons more accurately, leading to better blood flow after one year.
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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 166 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Jun 2026
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.
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient over 18 years old * Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1) * Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2) * ≥1 continuous permeable leg axis directly injecting the plantar arch * Rutherford 2-5 Exclusion Criteria: * Patient under personal protection regime (tutorship, guardianship) * Absence of arterial axis in permeable leg * Patient presenting a limb acute ischaemia (chart evolving since less than 14 days) * Patient without favorable element to consider healing * History of stents on the femoropopliteal axis * History of femoropopliteal bypass * Untreated stenosis ≥30% on the iliac axis and common femoral upstream * Popliteal lesion beyond the intercondylar notch (P2)
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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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Insitut Coeur-Poumon, CHU
RECRUITINGLille, 59037, France
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Other studies related to the condition(s) this trial covers.
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