Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions (TOCAF)

University Hospital, Lille

Status: Enrolling

Conditions: Superficial Femoral Artery Stenosis; Claudication; Ischemic Leg

Treatments: Device: femoropopliteal revascularization for TASC C or TASC D lesion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04434586

2019-A01055-52 (Other Identifier)

2018_88

Details and patient eligibility

About

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

angiography 2D

Sham Comparator group

Description:

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.

Treatment:

Device: femoropopliteal revascularization for TASC C or TASC D lesion

angiography 2D with OCT

Experimental group

Description:

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.

Treatment:

Device: femoropopliteal revascularization for TASC C or TASC D lesion