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Clinical Trials in France / NCT04434586
Recruiting Not applicable

Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

NCT04434586 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Lille
Phase
Not applicable
Started
2020-06-16
Last updated
2025-12-23

Condition(s) studied

Superficial Femoral Artery StenosisClaudicationIschemic Leg

Investigational drug(s) / intervention(s)

femoropopliteal revascularization for TASC C or TASC D lesion

femoropopliteal revascularization for TASC C or TASC D lesion: Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control

Study summary

This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Primary patency rate at 1 year. — at 12 months (+/- 2months)
    The permeability rate is defined by the echodoppler criteria: PVS\>2.4m/s or appearance of stenosis on the previously treated segment \>70%.

Trial sites (1)

FacilityCityRegionStatus
Insitut Coeur-Poumon, CHU Lille France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04434586 on ClinicalTrials.gov ↗ ← All trials in France