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NCT05155462 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05155462
Other study ID # 2018-A00868-47
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 9, 2019
Est. completion date December 9, 2021

Study information
Verified date November 2021
Source Ramsay Générale de Santé
Contact Jean-François Oudet
Phone 0683346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 330
Est. completion date December 9, 2021
Est. primary completion date April 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• One or two phone call
Phone call to collect patient data

Locations
Country Name City State
France Hôpital Privé Claude Galien Quincy-sous-Sénart

Sponsors (2)
Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 year
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