Claudication, Ischemic Leg, Superficial Femoral Artery Stenosis
Conditions
Keywords
femoral recanalization, optical coherence tomography (OCT), endovascular treatment, TASC-C,, TASC-D
Brief 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.
Interventions
DEVICEfemoropopliteal 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
Sponsors
Abbott
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate at 1 year. | at 1month (+/- 10days), 6months (+/- 1month) | — |
| Target lesion revascularisation | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability |
| Target vessel revascularisation | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability. |
| cost-effectiveness analyses | at 12 months (+/- 2months) | Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rutherford scale considered ordinal variable | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation). |
| Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study. | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm |
| Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months. | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | a questionnaire for evaluating walking impairment in patients Parameters: * difficulty walking a distance during the past month * difficulty walking at a certain speed during the past month * symptoms associated with walking impairment |
| Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months. | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | overall score on a numeric scale check the box that best describes your health today, 5 themes (mobility, autonomy of the person, common activities, pain / discomfort, anxiety / depression) |
| Limb Rescue Rate | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | — |
Countries
France
Contacts
Primary ContactJonathan Sobocinski, MD,PhD
Outcome results
None listed