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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Angioplasty
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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