Status:
RECRUITING
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Abbott
Conditions:
Superficial Femoral Artery Stenosis
Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
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 angiogr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04434586
Start Date
June 16 2020
End Date
June 1 2026
Last Update
December 23 2025
Active Locations (1)
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1
Insitut Coeur-Poumon, CHU
Lille, France, 59037