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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Angioplasty
• Intervention / Treatment: Other: One or two phone call

• Study Type: Observational
• Enrollment (Anticipated): 330

Contacts and Locations

Study Locations

• France
  • Quincy-sous-Sénart, France, 91480
    • Recruiting
    • Hôpital Privé Claude Galien
    • Contact: Thierry UNTERSEEH, Dr; Phone Number: 06.25.08.79.77; Email: t.unterseeh@icps.com.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient treated for defined symptomatic chronic lower extremity ischemia	Other: One or two phone call; Phone call to collect patient data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): April 9, 2020
• Study Completion (Anticipated): December 9, 2021

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2018-A00868-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No