Optical coherence tomography–guided femoral artery revascularization
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
This will test whether adding optical coherence tomography (OCT) to standard angiography during endovascular procedures helps doctors place balloons and stents more precisely in adults with complex femoropopliteal blockages (TASC C or D).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04434586 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with de novo TASC‑C or TASC‑D femoropopliteal lesions starting in the superficial femoral artery, at least one continuous patent distal leg artery, and Rutherford class 2–5 are the intended participants.
Not a fit: Patients with prior femoropopliteal stents or bypasses, acute limb ischemia under 14 days, absent distal runoff, untreated significant upstream iliac/common femoral stenosis, or those unable to consent are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, OCT guidance could improve stent apposition and balloon sizing, leading to better short-term revascularization outcomes and fewer technical failures.
How similar studies have performed: OCT is well established for coronary stenting and has shown promise in small peripheral artery series, but robust randomized evidence in complex femoropopliteal TASC C/D lesions is limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.