Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
NCT ID: NCT04434586
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
166 participants
INTERVENTIONAL
2020-06-16
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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angiography 2D
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.
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
angiography 2D with OCT
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Jonathan Sobocinski, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Insitut Coeur-Poumon, CHU
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Role: primary
References
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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.
Other Identifiers
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2019-A01055-52
Identifier Type: OTHER
Identifier Source: secondary_id
2018_88
Identifier Type: -
Identifier Source: org_study_id