MedDataX Logo

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

NCT ID: NCT05155462

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-09

Study Completion Date

2021-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease Angioplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient treated for defined symptomatic chronic lower extremity ischemia

One or two phone call

Intervention Type OTHER

Phone call to collect patient data

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

One or two phone call

Phone call to collect patient data

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Privé Claude Galien

Quincy-sous-Sénart, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean-François Oudet

Role: CONTACT

Phone: 0683346567

Email: [email protected]

Marie-Hélène Barba

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thierry UNTERSEEH, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A00868-47

Identifier Type: -

Identifier Source: org_study_id