Recruiting NA Superficial Femoral Artery Stenosis

New treatment option for Superficial Femoral Artery Stenosis

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

ClinicalTrials.gov ID: NCT04434586

What this study is testing

What it's testing
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.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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)

The study team makes the final eligibility decision.

Where it's taking place

  • Lille, France

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.