Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions (TOCAF)
Superficial Femoral Artery Stenosis, Claudication, Ischemic Leg
About this trial
This is an interventional treatment trial for Superficial Femoral Artery Stenosis focused on measuring femoral recanalization, optical coherence tomography (OCT), endovascular treatment, TASC-C,, TASC-D
Eligibility Criteria
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)
Sites / Locations
- Insitut Coeur-Poumon, CHURecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
angiography 2D
angiography 2D with OCT
Control group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed.
Experimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed.