Optical coherence tomography–guided femoral artery revascularization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with de novo femoropopliteal TASC‑C or TASC‑D lesions who meet inclusion criteria will undergo femoropopliteal revascularization at CHU Lille. Participants are assigned to a control group using standard 2D angiography alone or to an experimental group receiving 2D angiography plus intravascular OCT imaging during ballooning and stent deployment. OCT provides high-resolution cross-sectional and 3D views of the arterial lumen and device apposition, allowing operators to check balloon inflation and stent placement in more detail than angiography alone. The study compares procedural imaging findings and immediate revascularization results between the two groups.

Why it matters

Who can join: the full rules

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)

Where it's running

• Insitut Coeur-Poumon, CHU
  Lille, France Recruiting

Study contacts

• Principal investigator: Jonathan Sobocinski, MD,PhD — University Hospital, Lille
• Study coordinator: Jonathan Sobocinski, MD,PhD
• Email: jonathan.sobocinski@chru-lille.fr
• Phone: 0320445911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.