Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04434586

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

Led by University Hospital, Lille · Updated on 2025-12-23

166

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

A

Abbott

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Insitut Coeur-Poumon, CHU

Lille, France, 59037

Actively Recruiting

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Research Team

J

Jonathan Sobocinski, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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