Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: femoropopliteal revascularization for TASC C or TASC D lesion.
- Who it may be relevant to
- Registry conditions: Superficial Femoral Artery Stenosis, Claudication, Ischemic Leg. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device femoropopliteal 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
Primary outcome measures
- Primary patency rate at 1 year. [Time frame: at 12 months (+/- 2months)]
Secondary outcome measures (4)
- Primary patency rate at 1 year. [Time frame: at 1month (+/- 10days), 6months (+/- 1month)]
- Target lesion revascularisation [Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)]
- Target vessel revascularisation [Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)]
- cost-effectiveness analyses [Time frame: at 12 months (+/- 2months)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Insitut Coeur-Poumon, CHU — Lille
Publications
- Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4. PMID 32634565
Identifiers
NCT: NCT04434586 · 2018_88 · 2019-A01055-52