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Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

NCT04434586 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-12-23

No results posted yet for this study

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 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.

Conditions

  • Superficial Femoral Artery Stenosis
  • Claudication
  • Ischemic Leg

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

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Jonathan Sobocinski, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434586 on ClinicalTrials.gov