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

NCT05155462 | Unknown

• 1 other identifier: 2018-A00868-47
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Angioplasty

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient treated for defined symptomatic chronic lower extremity ischemia

Other: One or two phone call

Interventions

One or two phone call OTHER

Phone call to collect patient data

Patient treated for defined symptomatic chronic lower extremity ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: April 9, 2019
• Primary Completion: April 9, 2020
• Study Completion: December 9, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-11

Locations

FR (1)