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

• Conditions: Peripheral Arterial Disease; Angioplasty
• Interventions: Other: One or two phone call

• Registration Number: NCT05155462
• Lead Sponsor: Ramsay Générale de Santé

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-09
• Primary Completion: 2020-04-09
• Status Verified: 2021-11
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Study Completion: 2021-12-09
• Study First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient treated for defined symptomatic chronic lower extremity ischemia	One or two phone call	-

Primary Outcome Measures

Name	Time	Method
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	1 year	Lerich classification : stage I to IV Rutherford : stage 0 to 6

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France