Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
University Hospital, Lille
166 participants
Jun 16, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria8
- 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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Interventions
Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04434586