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

Sponsor

Ramsay Générale de Santé (Other)

Overall Status

Recruiting

CT.gov ID

NCT05155462

Collaborator

European Clinical Trial Experts Network (Other)

330

Enrollment

Location

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Angioplasty	Other: One or two phone call

Study Design

Study Type:

Observational

Anticipated Enrollment :

330 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 9, 2019

Actual Primary Completion Date :

Apr 9, 2020

Anticipated Study Completion Date :

Dec 9, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Patient treated for defined symptomatic chronic lower extremity ischemia

Other: One or two phone call

Phone call to collect patient data

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Privé Claude Galien	Quincy-sous-Sénart		France	91480

Sponsors and Collaborators

Ramsay Générale de Santé
European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramsay Générale de Santé

ClinicalTrials.gov Identifier:

NCT05155462

Other Study ID Numbers:

2018-A00868-47

First Posted:

Dec 13, 2021

Last Update Posted:

Dec 13, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Dec 13, 2021