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Status unknownNCT05155462Updated Dec 13, 2021

Analysis of the Different Strategies for Revascularization of the Lower Limbs by Peripheral Angioplasty

An observational study in Peripheral Arterial Disease and Angioplasty, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-13.

Sponsored by Ramsay Générale de Santé · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
330
Ages
18 Years and older
Sex
All
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Study summary

Peripheral arterial disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Many percutaneous treatment options have been developed: arteriectomy, naked stents, active balloons and active stents. Of these, only paclitaxel-active stents were successful in reducing the rates of restenosis and reoperation in patients with superficial femoral artery injury.The main objective is to study symptomatic improvement at 1 year of patients treated with revascularization of the lower limbs.

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Conditions studied

  • Peripheral Arterial Disease
  • Angioplasty
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In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 330 is above the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient 18 or over, treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a

Inclusion criteria

  • Patient treated by the peripheral angioplasty department of Claude Galien Hospital from January 2010 and with at least 1 year of follow-up after the revascularization procedure
  • Patient treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a
  • Stenosis or restenosis (history of balloon angioplasty, active balloon or bare stent)
  • Degree of stenosis ≥ 50% by angiographic evaluation visual, by CT scan or by Doppler ultrasound
  • Patient affiliated or beneficiary of a social security scheme
  • Patient aged 18 or over
  • Patient having been informed and not opposing this research

Exclusion criteria

Exclusion Criteria:

  • Medical history of myocardial infarction or stroke within 3 months of the revascularization procedure
  • Unstable angina at the time of the revascularization procedure
  • Sepsis at the time of the revascularization procedure
  • Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Hospitalized without consent
  • Pregnant, breastfeeding or parturient woman
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
330 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient treated for defined symptomatic chronic lower extremity ischemia

    Other: One or two phone call

Interventions

  • OtherOne or two phone call

    Phone call to collect patient data

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What researchers measure

Primary outcomes

  1. Symptomatic improvement will be assessed by the evolution of the Leriche and Rutherford classifications before the revascularization procedure and 1 year after the revascularization procedure

    Lerich classification : stage I to IV Rutherford : stage 0 to 6

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Hôpital Privé Claude Galien
    Quincy-sous-Sénart, 91480, France
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05155462
Lead sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
Responsible party
Sponsor
First posted
Dec 13, 2021
Start date
Apr 9, 2019
Primary completion
Apr 9, 2020
Completion
Dec 9, 2021 (estimated)
Last update
Dec 13, 2021

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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