Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05155462
Enrollment
330
Registered
2021-12-13
Start date
2019-04-09
Completion date
2021-12-09
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Peripheral Arterial Disease

Brief 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.

Interventions

OTHEROne or two phone call

Phone call to collect patient data

Sponsors

European Clinical Trial Experts Network
CollaboratorOTHER
Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Symptomatic improvement will be assessed by the evolution of the Leriche and Rutherford classifications before the revascularization procedure and 1 year after the revascularization procedure1 yearLerich classification : stage I to IV Rutherford : stage 0 to 6

Countries

France

Contacts

Primary ContactJean-François Oudet
jf.oudet@ecten.eu0683346567
Backup ContactMarie-Hélène Barba
mh.barba@ecten.eu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026