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

University Hospital, Lille166 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

166

Conditions

Superficial Femoral Artery Stenosis Claudication Ischemic Leg

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Primary patency rate at 1 year.

The permeability rate is defined by the echodoppler criteria: PVS\>2.4m/s or appearance of stenosis on the previously treated segment \>70%.

Time frame: at 12 months (+/- 2months)

Secondary Outcomes

Primary patency rate at 1 year.

Time frame: at 1month (+/- 10days), 6months (+/- 1month)

Target lesion revascularisation

corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability

Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

Target vessel revascularisation

corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.